AESGP Euro OTC News

Issue 329 | February 2021

BREXIT Revised Commission notice on Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period ______3

MEDICINES

REGULATORY NEWS ______4 CMDh highlights ______4 CMDh meeting with Interested Parties – Highlights ______6 EMA 5th Industry Stakeholder Platform on Research and Development Support – Highlights __ 7 EMA - Queries on Type IA/Bs variations, EU number requests, MAH Transfers and Article 61(3) for human medicinal products: new request process from 1 March 2021 ______7 Nitrosamine - EMA implementation plan published ______7 PHARMACOVIGILANCE ______8 GVP GL - Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3) ______8 HERBAL NEWS ______9 EMA HMPC highlights ______9 EMA HMPC launches 5 calls for data ______11 Draft public statement on Salvia miltiorrhiza Bunge, radix et rhizome ______11 Documents for comments ______12

FOOD

NOVEL FOOD ______13 EFSA opinion on the Safety of a change in the conditions of use of galacto-oligosaccharides as a novel food ingredient in food supplements ______13 Authorisations published in the Official Journal ______13 FOOD ADDITIVE RE-EVALUATION ______14 Call for data on vegetable carbon (E 153) ______14 Call for data on acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) _____ 15

Call for data on L(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) ______18

MEDICAL DEVICES

MDR IMPLEMENTATION ______22 19th Notified Body designated under the MDR ______22 EMA Stakeholders Workshop on Art.117 (27 November 2020) – Recording & Presentations __ 22 MDCG Meeting (7/8 December 2020) – Highlights ______22 EUROPEAN UDI WORKING GROUP ______22 Legacy Devices - UDI Device Documentation - Commission Guidance on the management of legacy devices published ______22

CROSS-SECTORIAL NEWS

EUROPEAN HEALTH UNION ______23 European Health Emergency Preparedness and Response Authority (HERA) - Inception impact assessment ______23 HEALTH DATA ______24 European Commission publication on EU Member States’ rules on health data in the light of GDPR ______24

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Brexit

Revised Commission notice on Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period

The European Commission has published a revised Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period. This Notice replaces the text of C(2020) 9264 published in the Official Journal on 23 December 2020.

This guidance notice is intended to facilitate the application of the EU’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period by indicating how the Commission will apply to this specific situation the relevant provisions of Directives 2001/82/EC, 2001/83/EC, 2001/20/EC of the European Parliament and of the Council and the Commission Delegated Regulation (EU) 2016/161. While this notice seeks to assist authorities and operators, only the Court of Justice of the European Union is competent to authoritatively interpret Union legislation.

Overall, the Notice does not introduce any significant changes compared to the Notice published in December 2020, but provides additional details on certain points.

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Medicines

REGULATORY NEWS

CMDh highlights

The CMDh has published the report of the CMDh meeting held on 26-27 January 2021.

CMDh practical guidance for MAHs of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (tracked)

The CMDh agreed an update of its practical guidance for MAH of NAPs (including MRP/DCP) in relation to the Art. 5(3) referral on nitrosamines to clarify for which products the call for review is applicable (if a nitrosamine evaluation has already taken place during the assessment of the MAA the call for review does not apply) and to inform MAHs what is expected for a newly identified nitrosamine risk after the assessment in the MAA or after the call for review is finalised. The submission details in step 2 have also been further clarified. The CMDh further agreed an update of the templates for the submission of step 1 and step 2 to reflect the outcome of the Art. 5(3) procedure.

United Kingdom's withdrawal from the European Union

On 31 December 2020, the transition period ended, under which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ has continued to be applicable to the UK. As of 1 January 2021, the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) applies. The IE/NI Protocol provides that the EU pharmaceutical acquis applies to and in the United Kingdom in respect of Northern Ireland. The EU-UK Trade and Cooperation Agreement is provisionally applicable since 1 January 2021, after having been agreed by EU and UK negotiators on 24 December 2020.

In addition, the European Commission has published a Notice on Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period. A revised version of the notice (2021/C 27/08) was published on 25 January 2021, replacing the original notice (C(2020) 9264), published on 23 December 2020. The CMDh is working on an update of its practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (tracked) to take into account the above- mentioned documents.

Marketing authorisation holders are reminded that batch control and release sites still located in the UK (GB) had to be removed from the marketing authorisation dossiers by 31 December 2020 and the respective variations should be submitted at the earliest opportunity, see also Practical Guidance Q/A 37.

Applicant’s response document in MRP and DCP for Marketing Authorisation Applications

The CMDh agreed an update of its guidance document on the Applicant’s response document in MRP and DCP for MAAs (tracked). With the update it is clarified that the applicant should submit as part of the response document an updated application form, each time the information in module 3 and 1.2 is modified, especially when these updates are related to manufacturers.

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Statistics

Mutual Recognition Procedures (MRP)

November 2019 10 3 December 2019 33 6 January 2020 29 4 February 2020 15 3 March 2020 22 4 April 2020 27 2 May 2020 21 4 June 2020 15 2 July - August 2020 41 7 September 2020 27 2 October 2020 17 7 November 2020 18 6 December 2020 33 4 0 10 20 30 40 50 60

Rx Non-prescription

Decentralised Procedures (DCP)

November 2019 68 4 December 2019 67 8 January 2020 58 5 February 2020 77 6 March 2020 75 3 April 2020 90 12 May 2020 90 8 June 2020 78 9 July - August 2020 149 14 September 2020 76 7 October 2020 55 9 November 2020 103 5 December 2020 59 3

0 20 40 60 80 100 120 140 160 180

Rx Non-prescription

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In addition, the CMDh published the minutes of the December CMDh meeting.

Working Party on Pharmacovigilance Procedures Worksharing

The WP chair gave a report from the December WP meeting including feedback from the HaRP group. The WP Chair presented the evaluation of the first two pilot phases of the HaRP project and the proposals to speed up the HaRP project. The CMDh adopted the Evaluation of the HaRP project and agreed to keep it as an internal document to be updated as needed. The WP Chair summarised the main achievements and activities of the HaRP and WP in 2020.

Joint CMDh/CMDv Variation Regulation Working Party

The WP Chair reported from December WP meeting. The WP was informed that following the agreement of CMDh/CMDv/EMA an update of the BPGs for type IA, type IB and grouped variations (Chapter 3, 4 and 6 of the BPGs for the Submission and Processing of Variations in MRP) will be published to delete the checklist, which is not needed anymore, following the latest update of the eAF. The WP discussed how to deal with comments during type IB variations and during validation in type IA/IB. The WP discussed the handling of ASMF version at the EoP and agreed to send a question to the ASMF WG on the need to update ASMF guidance documents. The WP received information on the publication of the EC pharmaceutical strategy and planned future updates on the variation system. The WP received a presentation on a survey to industry associations on work-sharing and its use for harmonisation of quality dossiers. The outcome of the survey revealed very positive feedback by industry and that expectations from the worksharing for harmonisation of quality dossiers were exceeded.

Variation introducing new ADRs

The CMDh discussed a case of parallel national variations to update the safety information of a product authorised nationally in several MSs, following an extensive database and literature search by the MAH. The product holds different indications in the MSs and some ADRs may be related only to a certain indication or therapeutic procedure (or may be related to off label use). It was discussed if these ADRs should also be included in the SmPC in MSs where the respective indication is not authorised. It was agreed that more information on the status of the variations in MSs and the authorised indications in those MSs is needed to decide if the MAH will be requested to resubmit the variation using variation worksharing. MSs were asked to provide this information until the January CMDh meeting for further discussion and decision on the next steps. MSs that have already finalised the variation were asked to provide the AR (in English, if possible).

Implementation of PRAC signal recommendation for ibuprofen, ketoprofen and fixed- dose combinations

MSs were reminded of the CMDh agreement published in the May 2020 CMDh press release on the implementation of the PRAC signal procedure for ibuprofen, ketoprofen and fixed-dose combinations on the potential risk of complications due to masking of symptoms of infection associated to the use of ibuprofen and ketoprofen containing products. Concerned MAHs were advised to submit an update of their product information, as necessary, via a type IB variation under category C.I.z, (as an adaptation of the proposed text to the existing PI wording will be necessary at national level). As it was considered that an adaptation of the proposed text to the existing PI wording will always be necessary the above- mentioned variation should be used.

CMDh meeting with Interested Parties – Highlights

The CMDh published the minutes of the CMDh meeting with Interested Parties of 11 November 2020.

The following topics have been discussed:

- Presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients - Brexit

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- Reference safety information - Multilingual Labelling in MRP/DCP - Splitting of MRP/DCP – presentation by AESGP - Procedural question related to the PSUFU process and procedural timelines

Under the topic of COVID-19, the post-meeting note regarding the scope of regulatory flexibilities can be highlighted:

Post-meeting note: An extension of the scope of the flexibilities beyond the current list of identified COVID-19 relevant products should not be easily possible as the current flexibilities are already quite broad and mature. The current adaptation is exceptional, risk-based and targeted, and any call for any additional measure should be substantiated with further data.

EMA 5th Industry Stakeholder Platform on Research and Development Support – Highlights

The EMA published the Highlight report of the 5th Industry stakeholder platform on research and development support which was held virtually on 16 November 2020.

The EMA presentations given at the meeting have also been made available and can be accessed here.

EMA - Queries on Type IA/Bs variations, EU number requests, MAH Transfers and Article 61(3) for human medicinal products: new request process from 1 March 2021

The EMA has informed that the different query mailboxes for Type IAs and type IBs variations, New EU number, MAH transfers and Article 61(3) notifications for human medicinal products are being decommissioned by 1 March 2021.

MAHs of centrally authorised medicinal products who have questions on any upcoming Type IAs or Type IBs variations, New EU number, MAH transfers or Article 61(3) notifications will be asked to contact EMA by raising a ticket via EMA Service Desk with a clear identification of the scope of the query, i.e. “Post-authorisation queries” and relevant scope sub-option to facilitate the timely management of the questions.

From the date of this communication and the date of mandatory implementation, queries submitted to the existing mailboxes will still be handled, but from 1 March, only the queries submitted via the EMA Service Desk will be addressed.

Note: if you do not have an EMA Account to use EMA service desk, you may create one via the EMA Account Management portal.

Nitrosamine - EMA implementation plan published

The EMA has published the European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines which clarifies how the European Medicines Regulatory Network, together with the European Directorate for the Quality of Medicines & HealthCare, will be implementing the outcome of the CHMP's review. This includes specific measures that the network will take if nitrosamines are detected in a medicine.

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PHARMACOVIGILANCE

GVP GL - Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

The EMA has published the following draft guidance documents for public consultation:

- Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

Risk management includes the identification, characterisation (including quantification), prevention and minimisation of risks. Risk management systems consist of pharmacovigilance activities and interventions relating to individual medicinal products for this purpose, including the assessment of the effectiveness of those activities and interventions, in accordance with Article 1(28b) of Directive 2001/83/EC. The objectives of risk minimisation are achieved through the implementation of risk minimisation measures (RMM) required by the competent authorities and generation of evidence that these measures are effective.

This GVP Module should be read together with GVP Module V on risk management systems as documented through risk management plans (RMPs) and on details of routine RMM, GVP Module VIII on post-authorisation safety studies (PASS), GVP Module XV on safety communication and the Addenda of this GVP Module as referenced. Marketing authorisation holders should also take into consideration specifications and any specific processes that are already in place in Member States.

The EMA is specifically seeking comments on the need and suggestions for possibly replacing the established term ’controlled access programmes’ to avoid confusion with the concepts ‘access to medicines’ and ‘controlled substance’.

- Guideline on good pharmacovigilance practices (GVP) 4 Module XVI Addendum II – Methods for effectiveness evaluation

This Addendum to GVP Module XVI provides additional guidance for marketing authorisation holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimisation measures (RMM) in line with the principles for RMM effectiveness evaluation laid down in GVP Module XVI. Depending on the risk minimisation objective, studies evaluating RMM effectiveness may integrate different quantitative measurements and qualitative research approaches to evaluate risk minimisation outcomes for individual tools or sets of RMM described in GVP Module XVI.

Together, these two GVP documents are meant to clarify and enhance tools for risk minimisation measures, and strengthen methods for studying the effectiveness of the implementation of risk minimisation measures and the possible need for adjustments of risk minimisation measures in the interest of patient safety. Guidance on the important collaboration with patient and healthcare representatives in the related regulatory processes is included too.

The EMA has also published the updated Introductory cover note on the Guidelines on good pharmacovigilance practices.

Members can send their comments on the above draft guidelines to AESGP using this template by 14 April 2021.

Both draft documents and changes have been presented in detail at the EMA 15th industry stakeholder platform on operation of European Union (EU) pharmacovigilance.

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HERBAL NEWS

EMA HMPC highlights

The report from the 97th meeting of the EMA Committee on Herbal Medicinal Products (HMPC) held remotely on 11-13 January 2021 has been published.

New European Union herbal monographs

The HMPC adopted the following final EU herbal monograph after public consultation:

- EU herbal monograph on Aloysiae citriodorae folium (by consensus)

The HMPC adopted further the following draft public statement for 3-months public consultation until 30 April 2021:

- Public statement on Salviae miltiorrhizae radix et rhizoma

The document explains the reasons why the HMPC could not establish a monograph at present. Interested parties are invited to comment and provide additional data.

Revised European Union herbal monograph

The HMPC adopted after systematic review and revision the following draft revised monograph for 3- months public consultation until 30 April 2021:

- Revised EU herbal monograph on Orthosiphonis folium

European Union herbal monograph review

Upon recommendation from the Rapporteur, the HMPC decided after systematic review according to procedure EMA/HMPC/124695/2011 Rev. 2 to start the revision procedure because new data were identified that could change the

- EU herbal monograph on Agropyri repentis rhizoma

The revision of the monograph will be added to the HMPC work programme.

Calls for scientific data

HMPC decided to start the following procedures in line with its work plan 2021 for which new calls for data will be published for:

New assessments to be started in 2021

- Cnici benedicti herba - Combination Hyperici herba / Cimicifugae rhizoma

Periodic reviews to be started in 2021

- Arnicae flos - Camelliae sinensis non fermentatum folium - Cichorii intybi radix - Cucurbitae semen - Curcumae xanthorrhizae rhizoma

- Eucalypti aetheroleum - Eucalypti folium

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- Fraxini folium - Ginseng radix - Grindeliae herba - Hippocastani cortex - Juglandis folium - Levistici radix

- Lichen islandicus - Liquiritiae radix - Marrubii herba - Origani dictamni herba - Paulliniae semen - Rhodiolae roseae rhizoma et radix - Tiliae flos - Urticae radix

HMPC work plan 2021

The HMPC adopted its work plan 2021 including Annex 1 for monograph / list entry assessment work and Annex 2 for guideline development. The activities outlined in the work plan for 2021 have been agreed taking into consideration the ongoing phase of EMA’s business continuity due to the Covid-19 pandemic.

EU herbal monographs in preparation

New assessment – drafts

The Committee agreed on draft documents for Species digestivae / stomachicae and on Vaccinii macrocarpi fructus for peer review and possible release for public consultation at the HMPC March 2021 meeting.

The HMPC continued its assessment of Centellae asiaticae herba and re-instated the discussion on Cisti creticii folium.

Monograph reviews

The Committee discussed the availability of new data and the need to revise monographs for Cinnamomi corticis aetheroleum and Cinnamomi cortex for possible decision at the HMPC March 2021 meeting. The members also discussed systematic review of Fumariae herba.

Monograph revisions – drafts

The HMPC endorsed the documents on Hyperici herba (WEU/TU) and on Trigonellae foenugraeci semen for peer review and possible release for public consultation at the HMPC March 2021 meeting.

The HMPC had initial discussions on the revision of Foeniculi amari fructus, Foeniculi amari fructus aetheroleum, Foeniculi dulcis fructus and Sabalis serrulatae fructus.

In addition, the EMA published the minutes of the HMPC November 2020 meeting.

Public statement on the use of herbal medicinal products containing estragole

Action: for adoption

Outcome: Final public statement on the use of herbal medicinal products containing estragole adopted by consensus. HMPC agreed to initiate the communication between CHMP/SWP and CMDh before the final publication.

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EMA HMPC launches 5 calls for data

EMA HMPC has launched calls for submission of scientific data for:

- Periodic review of the monograph on Arnicae flos - Periodic review of the monograph on Camelliae sinensis non fermentatum folium - Periodic review of the monograph on Cichorii intybi radix - Periodic review of the monograph on Cucurbitae semen - Periodic review of the monograph on Curcumae xanthorrhizae rhizoma

As stated in the HMPC Procedure for calls for scientific data for use in HMPC assessment work, unpublished proprietary data may be included. However, in this case the consent of the data owner is a necessary requirement and therefore it must be provided simultaneously with the contributions. If the party submitting the data is not the data owner, the consent of the latter is needed. If the data owner is the interested party itself, the voluntary submission of the data as a contribution to the HMPC assessment constitutes consent that the HMPC may evaluate and use the submitted data in the course of the procedure announced in the call for scientific data.

Before its publication, the owner of the data will be given the opportunity to review the assessment report to request the removal of any confidential data. Such request must be duly justified by evidencing the confidential nature of the data (e.g. that it includes confidential intellectual property). The HMPC will consider such requests on a case-by-case basis.

In addition, it is reminded that interested parties will not incur in any liability as to the use intended by the HMPC by forwarding the bibliographic literature to the Committee.

Members having any data on these plants are kindly invited to send them to AESGP by 16 April 2021 following the above referred guidance outlined in the Procedure for calls for scientific data for use in HMPC assessment work for the submission of data.

Draft public statement on Salvia miltiorrhiza Bunge, radix et rhizome

Further to its adoption by the EMA Committee on Herbal Medicinal Products (HMPC) in January 2021, the draft Public statement on Salvia miltiorrhiza Bunge, radix et rhizome has been released for consultation.

PROBLEM STATEMENT

The HMPC/MLWP decided to prepare a European Union herbal monograph on Salvia miltiorrhiza Bunge, radix et rhizoma as announced in the 2018 MLWP work programme.

A comprehensive literature search was conducted and available data, including information on products on the market in the European Union, were assessed in relation to the requirements laid down in Directive 2001/83/EC and its Annex I, in particular Article 1, Article 10a and Chapter 2a.

The HMPC/MLWP concluded that the following requirements for the establishment of a European Union herbal monograph on traditional or well-established herbal medicinal products containing Salvia miltiorrhiza Bunge, radix et rhizome are not fulfilled:

- The requirement laid down in Article 10a of Directive 2001/83/EC that the active substance has a recognised efficacy and an acceptable level of safety and that the period of well-established medicinal use has elapsed - The requirement laid down in Article 16a(1)(a) of Directive 2001/83/EC that the indications are “exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment” - The requirement laid down in Article 16a(1)(d) of Directive 2001/83/EC that “the period of traditional use as laid down on Article 16c(1)(c) has elapsed” - The requirement laid down in Article 16a(1)(e) of Directive 2001/83/EC that “the data on the traditional use of the medicinal product are sufficient; in particular the product proves not to be

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harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience”

The HMPC acknowledges the existence of numerous publications on the use in the European Union of Salvia miltiorrhiza Bunge, radix et rhizoma or constituents thereof. However, often an appropriate description of herbal substance or herbal preparations used are missing. Available data are not sufficient to establish a European Union monograph at present.

CONCLUSION

Based on the above-mentioned concerns, the HMPC is of the opinion that a European Union herbal monograph on Salvia miltiorrhiza Bunge, radix et rhizoma cannot be established. To read more about the assessment carried out, a link is provided to the page where to access the draft assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma and its list of references.

The draft assessment report and draft list of references supporting the assessment of Salviae miltiorrhizae rhizoma have also been published.

Members can send their comments on the draft public statement to AESGP using this template by 9 April 2021.

Documents for comments

DOCUMENT AESGP DEADLINE FOR COMMENTS

EMA HMPC draft revised European Union herbal Comments can be sent to AESGP using this monograph on Orthosiphon aristatus (Blume) Miq. template by 9 April 2021 var. aristatus, folium

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Food

NOVEL FOOD

EFSA opinion on the Safety of a change in the conditions of use of galacto- oligosaccharides as a novel food ingredient in food supplements

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) published its opinion on the Safety of a change in the conditions of use of galacto-oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283.

The Panel concludes that the proposed increase in the maximum level of galacto-oligosaccharides as a novel food in food supplements is safe under the proposed changes in conditions of use.

The novel food which is the subject of the application, is mainly composed of galacto-oligosaccharides (GOS), which consist of different galactosyl residues (two to nine) linked to a terminal glucose by a b- glycosidic bond. The novel food is produced enzymatically by two b-galactosidases and also contains lactose, glucose and limited amounts of other monosaccharides.

The proposed expanded use increases the maximum level in food supplements (as defined in Directive 2002/46/EC)4from 0.333 kg GOS/kg food supplement (33.3%) to 0.450 kg GOS/kg food supplement (45.0%). No new food uses or other increases to the already approved use levels are being proposed.

The information provided on the proposed use levels and anticipated intake do not raise safety concerns. The Panel concludes that the proposed increase in the maximum level of galacto-oligosaccharides as novel food in food supplements is safe under the proposed changes in conditions of use.

Authorisations published in the Official Journal

Following adoption by the Standing Committee, the following Commission Implementing Regulations have been published in the Official Journal:

- Commission Implementing Regulation (EU) 2021/50 of 22 January 2021 authorising an extension of use and a change in the specifications of the novel food ‘2′- fucosyllactose/difucosyllactose mixture’ and amending Implementing Regulation (EU) 2017/2470

- Commission Implementing Regulation (EU) 2021/51 of 22 January 2021 authorising a change of the conditions of use of the novel food ‘trans-resveratrol’ under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the food supplements containing it shall be “Trans-resveratrol”. 2. The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

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- Commission Implementing Regulation (EU) 2021/82 of 27 January 2021 authorising the placing on the market of 6’-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

o For a period of five years from the date of entry into force of this Regulation only the Applicant is authorised to place on the market within the Union the novel food referred to in the implementing regulation, unless a subsequent applicant obtains authorisation for the same novel food without reference to the data protected pursuant this Regulation or with the agreement of the applicant.

- Commission Implementing Regulation (EU) 2021/96 of 28 January 2021 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

FOOD ADDITIVE RE-EVALUATION

Call for data on vegetable carbon (E 153)

The European Commission has published a Call for technical data on the permitted food additive vegetable carbon (E 153).

As this call concerns only technical data, the 2-step procedure used in previous calls for scientific and technical data is not followed. Therefore, the deadline of this call is the final deadline for submission of the requested technical data. The requested data need to be submitted by 14 August 2021.

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) delivered a scientific opinion re-evaluating the safety of vegetable carbon (E 153) when used as a food additive in April 2012. Vegetable carbon has been evaluated previously by the Scientific Committee for Food (SCF) (1977, 1983) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (1970, 1977, 1987). Neither Committee established an ADI for vegetable carbon, but the SCF concluded that vegetable carbon could be used in food.

With reference to the conclusions and recommendations in the Scientific Opinion on the re-evaluation of vegetable carbon (E 153) as a food additive by EFSA, information for vegetable carbon (E 153) is sought on:

The characterisation of all the different commercial preparations of the food additive vegetable carbon (E 153) from non-consecutive batches of each preparation, in relation to:

- Analytical data, if possible supported by certificate of analysis, on current levels of aluminium, arsenic, lead, mercury and cadmium in commercial samples of the food additive; - The lowest technologically achievable level for aluminium, arsenic, lead, mercury and cadmium in order to adequately propose maximum limits in the specifications; - Analytical data, if possible supported by certificate of analysis, on current levels of benz[a]anthracene, benzo[b]fluoranthene, benzo[j]fluoranthene, benzo[k]fluoranthene, benzo[ghi]perylene, benzo[a]pyrene, chrysene, cyclopenta[cd]pyrene, dibenz[a,h]anthracene, dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene, indeno[1,2,3- cd]pyrene, 5-methylchrysene, and benzo[c]fluorene in commercial samples of the food additive, using a validated analytical method, preferably based on mass spectrometry, of appropriate sensitivity (LOD of 0.1 μg/kg per individual PAH;

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- The lowest technologically achievable level for the above-listed 16 priority PAHs in order to adequately propose maximum limits in the specifications at least for benzo(a)pyrene, as well as for the sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene; - Because of their potential importance in toxicokinetics and toxicological effects, particle size and particle size distribution should be included in the EU specifications for the food additive vegetable carbon (E 153) in Commission Regulation (EU) No 231/2012. Therefore, detailed and comprehensive proposed specifications for the characterisation of the fraction of nanoparticles present in the food additive vegetable carbon (E 153) should be submitted. Information on particle size and particle size distribution for the food additive vegetable carbon (E 153) supported by analytical data, in line with the “EFSA guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health”, is requested. In addition, the latest indications from the EFSA “Draft Guidance on technical requirement for regulated food and feed product applications to establish the presence of small particles including nanoparticles”, published recently for public consultation, may be considered. The information provided should allow the establishment of parameters in the EU specifications for vegetable carbon (E 153) that fully characterise the material used as a food additive.

The analyses should be performed with appropriate analytical methods, applying state of the art techniques. Specific data on the methods of analysis used should be provided. These include, but are not limited to, e.g. the principle of the method, the scope of the method (i.e. the range of sample types that the method is used for), the concentration units used to express the analytical result(s), validation of the method (in particular limit of detection (LOD) and (LOQ).

Business operators are requested to submit the above-indicated data by the agreed deadline using the online platform CIRCABC. The “Guidance for online data submission on Food Improvement Agents via CIRCABC Sante-Cad-In Group” provides practical information on how to use the CIRCABC platform for the online submissions.

Once the new data are received, they will be submitted to EFSA for evaluation and preparation of a scientific opinion, if appropriate. Once EFSA has assessed the new data, the current authorisation of the additive(s) may be revised, if needed. If business operators do not provide the requested data (by the predefined deadline) the present authorisation will be revised based on EFSA’s current scientific opinion and the additive(s) may be removed from the Union list of permitted additives. The same applies if the new data submitted is not sufficient for EFSA to conclude the risk assessment, since there will be no successive requests for additional data.

Call for data on acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f)

The European Commission has published a Call for technical data on the permitted food additives acetic acid esters of mono- and diglycerides of fatty acids (E 472a), lactic acid esters of mono- and diglycerides of fatty acids (E 472b), tartaric acid esters of mono- and diglycerides of fatty acids (E 472d), mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472e) and mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472f).

With reference to the conclusions and recommendations in the Scientific Opinion on the reevaluation of acetic acid, lactic acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a, b, d, e and f) as food additives by EFSA, information is sought on:

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1. Information related to the specifications

a. For tartaric acid esters of mono- and diglycerides of fatty acids (E 472d), mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472e) and mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472f):

- Information on all manufacturing processes used for the production of these food additives; - In case L(+)-tartaric from chemical/microbiological synthesis is used for the production of any of these food additives, information on levels of heavy metals (e.g. vanadium, molybdenum or tungsten) resulting from the use of any catalyst should also be provided (as requested in the call for data on L(+)-tartaric acid (E 334) (see https://ec.europa.eu/food/safety/food_improvement_agents/additives/re-evaluation_en); - Analytical data, supported by certificate of analysis, on current levels of oxalates in commercial samples of E 472d, e and f; - Data on the lowest technologically achievable level for oxalates in E 472d, e and f, in order to adequately define a maximum limit in the specifications for these food additives.

b. For acetic acid esters of mono- and diglycerides of fatty acids (E 472a), lactic acid esters of mono- and diglycerides of fatty acids (E 472b), tartaric acid esters of monoand diglycerides of fatty acids (E 472d), mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472e) and mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472f):

- Analytical data, if possible supported by certificate of analysis, on current levels of arsenic, lead and mercury in commercial samples of these food additives; - The lowest technologically achievable level for arsenic, lead and mercury and cadmium in order to adequately define maximum limits in the specifications for these food additives; - analytical data, if possible supported by certificate of analysis, on current levels of impurities of toxicological concern (e.g. butanetriols, acrolein, chlorinated compounds and 3- monochloropropane-1,2-diol) as identified in the EU specifications for the food additive glycerol (E 422), which can be used in the manufacturing process of E 472a, b, d, e and f, in commercial samples of these food additives; - the lowest technologically achievable level for impurities of toxicological concern (e.g. butanetriols, acrolein, chlorinated compounds and 3-monochloropropane-1,2-diol) in order to adequately define their maximum limits in the specifications for E 472a, b, d, e and f; - analytical data, if possible supported by certificate of analysis, on current levels of any impurity present in glycerol as mentioned in the call for data on glycerol (E 422)4 , which can be used in the manufacturing process of E 472a, b, d, e and f, in commercial samples of these food additives; - the lowest technologically achievable level for any impurity which could be formed during the manufacturing processes of glycerol and be present in E 472a, b, d, e and f, in order to adequately define their maximum limits in their specifications; - Analytical data, if possible supported by certificate of analysis, on current levels of trans- fatty acids in commercial samples of E 472a, b, d, e and f; - the lowest technologically achievable level for trans-fatty acids in E 472a, b, d, e and f in order to adequately define a maximum limit in the specifications for these food additives; - Analytical data, if possible supported by certificate of analysis, on current levels of erucic acid in commercial samples of E 472a, b, d, e and f; - the lowest technologically achievable level for erucic acid in E 472a, b, d, e and f in order to adequately define a maximum limit in the specifications for these food additives; - Analytical data, if possible supported by certificate of analysis, on current levels of any compound of toxicological concern (e.g. 3-MCPD or glycidyl esters), which can be produced under certain processing conditions from the food additives E 472a, b, d, e and f; - the lowest technologically achievable level of any compound of toxicological concern (e.g. 3- MCPD or glycidyl esters), which can be produced under certain processing conditions from the food additives E 472a, b, d, e and f.

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2. Data on uses/use levels of the food additives tartaric acid esters of mono- and diglycerides of fatty acids (E 472d), mono- and diacetyltartaric acid esters of mono and diglycerides of fatty acids (E 472e) and mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472f)

Since EFSA has established a numerical Acceptable Daily Intake (ADI) for the food additives E 472d, e and f, numerical maximum use levels should be defined for all their permited uses. Therefore, all current authorisations at quantum satis should be revised.

a. Uses in accordance with Annex II, Part E of Regulation (EC) No 1333/2008

E 472d, e and f are included in the Group I of food additives and they are therefore authorised in the 66 food categories in which the use of Group I of food additives is permitted.

For all the food categories in which E 472d, e and f are permitted in accordance with Annex II, Part E of Regulation (EC) No 1333/2008, food business operators are requested to provide:

- data on normal and maximum use levels of E 472d, e and f in each food category. A numerical maximum level needs to be provided (the quantum satis principle should not be applied for these food additives). For dried and/or concentrated foods which need to be reconstituted, the level provided shall apply to the food as reconstituted according to the instructions on the label taking into account the minimum dilution factor; - information on whether the reported use and use levels concern all different foodstuffs belonging to a food category or only certain foodstuffs (to potentially allow the definition of appropriate restrictions/exceptions of use in Annex II, Part E of Regulation (EC) No 1333/2008).

Data on use levels of E 472d, e and f in the food categories in which these food additives are currently permitted should be reported using the template developed for this purpose (MS Excel® file “Data on use of E 472d, e and f in accordance with Annex II, Part E, of Regulation (EC) No 1333-2008.xls”), following the instructions provided in the template.

If no data are provided for a food category in which the intentional addition of E 472d, e and f as food additives is currently authorised, it will be considered that there is no interest that the use of E 472d, e and/or f as food additives remains authorised in that food category. Consequently, the authorisation for the use of E 472d, e and/or f as food additives in that food category will be withdrawn.

Therefore, if an interested party has information that E 472d, e and/or f are not used in one or several food categories in which they are currently authorised, this information should also be provided. Such information will be of course cross-checked with information sent by all interested parties replying to the call.

b. Uses in accordance with Annex III, Part 2, 3, 4 and Section A of Part 5 of Regulation (EC) No 1333/2008

E 472d, e and f are also authorised according to Annex III of Regulation (EC) No 1333/2008 as follows:

- as food additives in food additives having a function of carrier in colours and fat-soluble antioxidants with a maximum level in the preparations/final food at quantum satis (Annex III, Part 1) (only E 472e). - as food additives in food additives having a function other than a carrier with a maximum level in the preparations/final food at quantum satis (Annex III, Part 2). - as food additives in food enzymes with a maximum level in the preparations/final food at quantum satis (Annex III, Part 3). - as food additives including carriers in all food flavourings with a maximum level in the preparations/final food at quantum satis (Annex III, Part 4).

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- as food additives in all nutrients except nutrients intended to be used in foodstuffs for infants and young children, with a maximum level in the nutrient preparations/final food at quantum satis (Annex III, Part 5, Section A).

For all the uses for which E 472d, e and f are permitted in accordance with Annex III of Regulation (EC) No 1333/2008, food business operators are requested to provide:

- data on maximum use levels of E 472d, e and f in the preparation as well as in the final food, A numerical maximum level needs to be provided (the quantum satis principle should not be applied for these food additives); - information on whether the reported use concerns all preparations or only certain preparations (when appropriate).

Data on use levels of E 472d, e and f in accordance with Annex III of Regulation (EC) No 1333- 2008 should be reported using the attached template developed for this purpose (MS Excel® file “Data on use of E 472d, e and f in accordance with Annex III of Regulation (EC) No 1333- 2008.xls”), following the instructions provided in the template.

If no data are provided for a currently authorised use of E 472d, e and f as food additives in accordance with Annex III, Part 1, 2, 3, 4 or 5, it will be considered that there is no interest that that use remains authorised.

Consequently, that authorisation for the use E 472d, e and f as food additives in that food category will be withdrawn. Therefore, if an interested party has information that E 472d, e and f are not used in accordance with Annex III, Part 1, 2, 3, 4 or 5, this information should also be provided. Such information will be of course cross-checked with information sent by all interested parties replying to the call.

Call for data on L(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354)

The European Commission has published a Call for technical data on the permitted food additives L(+)- tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354).

With reference to the conclusions and recommendations in the Scientific Opinion on the reevaluation of L(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) as food additives by EFSA, information is sought on:

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1. Information related to the specifications

For monosodium tartrate (E 335 (i)), disodium tartrate (E 335 (ii)), monopotassium tartrate (E 336 (i)), dipotassium tartrate (E 336 (ii)), potassium sodium tartrate (E 337) and calcium tartrate (E 354):

- Information on all manufacturing processes used for the production of each of these food additives; - Information on the specific rotation of E 335 (i), E 335 (ii), E 336 (i), E 336 (ii) and E 337, in order to introduce a provision for specific rotation in the “identification” section of their specifications, to ensure the exclusive use of the authorised L(+)-stereoisomer in these food additives; - In case a chemical/microbiological manufacturing process is used for the production of any of these food additives, information on levels of heavy metals (e.g. vanadium, molybdenum or tungsten) resulting from the use of any catalyst should also be provided (as requested below for E 334);

For L(+)-tartaric acid (E 334):

- Analytical data, if possible supported by certificate of analysis, in commercial samples of the food additive E 334, on heavy metals (e.g. vanadium, molybdenum or tungsten) resulting from the use of any catalyst for the chemical/microbiological production of E 334 using Rhodococcus ruber strain CM001 or Rhodococcus sp strain USA-AN012; - The lowest technologically achievable level for heavy metals (e.g. vanadium, molybdenum or tungsten) resulting from the use of any catalyst for the chemical/microbiological production of E 334 using Rhodococcus ruber strain CM001 or Rhodococcus sp strain USA-AN012, in order to adequately define maximum limits in the specifications for this food additive;

For L(+)-tartaric acid (E 334), monosodium tartrate (E 335 (i)), disodium tartrate (E 335 (ii)), monopotassium tartrate (E 336 (i)), dipotassium tartrate (E 336 (ii)), potassium sodium tartrate (E 337) and calcium tartrate (E 354):

2. Data on uses/use levels of the food additives L(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354)

Since EFSA has established a numerical Acceptable Daily Intake (ADI) for the food additives tartaric acid tartrates (E 334-337, 354), numerical maximum use levels should be defined for all their permitted uses. Therefore, all current authorisations at quantum satis should be revised. a. Uses in accordance with Annex II, Part E of Regulation (EC) No 1333/2008 Tartaric acid and tartrates (E 334-337, E 354) are included in the Group I of food additives and they are therefore authorised in the 66 food categories in which the use of Group I of food additives is permitted. In addition, there are specific authorisations for one or more of these food additives in 15 food categories.

For all the food categories in which E 334-337 and E 354 are permitted in accordance with Annex II, Part E of Regulation (EC) No 1333/2008, food business operators are requested to provide:

- data on normal and maximum use levels of E 334-337 and E 354 in each food category, expressed as tartaric acid, indicating whether all additives of the group E 334-337, E 354 tartaric acid-tartrates are used or only some/one of them. If E 334-337 and E 354 are used in combination (as a group) the use level provided should be applicable to the group (and not to each member of the group). A numerical maximum level needs to be provided (the quantum satis principle should not be applied for these food additives). For dried and/or concentrated

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foods which need to be reconstituted, the level provided shall apply to the food 4 as reconstituted according to the instructions on the label taking into account the minimum dilution factor; - information on whether the reported use and use levels concern all different foodstuffs belonging to a food category or only certain foodstuffs (to potentially allow the definition of appropriate restrictions/exceptions of use in Annex II, Part E of Regulation (EC) No 1333/2008)

Data on use levels of E 334-337 and E 354 in the food categories in which these food additives are currently permitted should be reported using the template developed for this purpose (MS Excel® file “Data on use of E 334-337 and E 354 in accordance with Annex II, Part E, of Regulation (EC) No 1333-2008.xls”), following the instructions provided in the template. If no data are provided for a food category in which the intentional addition of E 334-337 and E 354 as food additives is currently authorised, it will be considered that there is no interest that the use of E 334-337 and E 354 as food additives remains authorised in that food category. Consequently, the authorisation for the use of E 334-337 and E 354 as food additives in that food category will be withdrawn. Therefore, if an interested party has information that E 334-337 and E 354 are not used in one or several food categories in which they are currently authorised, this information should also be provided. Such information will be of course cross-checked with information sent by all interested parties replying to the call. b. Uses in accordance with Annex III, Part 2, 3, 4 and Section A of Part 5 of Regulation (EC) No 1333/2008

Tartaric acid and tartrates (E 334-337, E 354) are also authorised according to Annex III of Regulation (EC) No 1333/2008 as follows:

- as food additives in food additives having a function other than a carrier with a maximum level in the products (beverages or not) at quantum satis (Annex III, Part 2). - as food additives in food enzymes with a maximum level in the products (beverages or not) at quantum satis (Annex III, Part 3). - as food additives including carriers in all food flavourings with a maximum level in the products (beverages or not) at quantum satis (Annex III, Part 4). - as food additives in all nutrients except nutrients intended to be used in foodstuffs for infants and young children, with a maximum level in the nutrient at quantum satis (Annex III, Part 5, Section A).

For all the uses for which E 334-337 and E 354 are permitted in accordance with Annex III of Regulation (EC) No 1333/2008, food business operators are requested to provide:

- data on maximum use levels of E 334-337 and E 354 in the preparation as well as in the final food, expressed as tartaric acid, indicating whether all these additives of the group E 334- 337, E 354 tartaric acid-tartrates are used or only some/one of them. If E 334-337 and E 354 are used in combination (as a group) the use level provided should be applicable to the group (and not to each member of the group). A numerical maximum level needs to be provided (the quantum satis principle should not be applied for these food additives); - information on whether the reported use concerns all preparations or only certain preparations (when appropriate).

Data on use levels of E 334-337 and E 354 in accordance with Annex III of Regulation (EC) No 1333-2008 should be reported using the attached template developed for this purpose (MS Excel® file “Data on use of E 334-337 and E 354 in accordance with Annex III of Regulation (EC) No 1333- 2008.xls”), following the instructions provided in the template. 5 If no data are provided for a currently authorised use of E 334-337 and E 354 as food additives in accordance with Annex III, Part II, III, IV or V, it will be considered that there is no interest that that use remains authorised. Consequently, that authorisation for the use E 334-337 and E 354 as food additives in that food category will be withdrawn. Therefore, if an interested party has information that E 334-337 and E 354 are not used in accordance with Annex III, Part II, III, IV or V, this information should also be provided. Such information will be of course cross-checked with information sent by all interested parties replying to the call.

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Medical

Devices

MDR IMPLEMENTATION

19th Notified Body designated under the MDR

Italy-based notified body ‘ISTITUTO SUPERIORE DI SANITA’ has been notified as the 19th* Notified Body under the MDR (after BSI UK*, TÜV SÜD, DEKRA, IMQ, TÜV Rheinland, DARE!! Services, BSI NL, DEKRA Certification B.V, Medcert, DNV GL Presafe AS, NSAI, CE Certiso Orvos, MDC MEDICAL DEVICE CERTIFICATION GMBH, Intertek Medical Notified Body AB, GMED, DQS Medizinprodukte GmbH, 3EC International a.s., UDEM Adriatic, SGS FIMKO OY).

More details can be found on the Commission database NANDO (New Approach Notified and Designated Organisations).

*Adjustment of designations in the NANDO database: the designated UK notified body “BSI UK” under the MDR and IVDR, as well as under the current medical device directives, has now been removed from the NANDO database given the fact that the EU/UK Brexit withdrawal agreement period came to an end.

EMA Stakeholders Workshop on Art.117 (27 November 2020) – Recording & Presentations

The EMA has made available the presentations and video recording from the multi-stakeholder workshop on implementation of MDR Article 117 on drug-device combinations that took place on 27 November 2020.

The documents and recording can be accessed here.

MDCG Meeting (7/8 December 2020) – Highlights

The Commission published the minutes of the last MDCG meeting (without stakeholders) that took place on 7-8 December 2020.

The minutes are available here.

EUROPEAN UDI WORKING GROUP

Legacy Devices - UDI Device Documentation - Commission Guidance on the management of legacy devices published

The Commission has published a Guidance on the Management of Legacy Devices. The Guidance is available here.

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Cross-Sectorial

News

EUROPEAN HEALTH UNION

European Health Emergency Preparedness and Response Authority (HERA) - Inception impact assessment

The European Commission has published the draft inception impact assessment on the European Health Emergency Preparedness and Response Authority (HERA), which can be accessed here.

The inception impact assessment outlines the Commission’s initiative presented in its Communication on Building a European Health Union to establish a European Health Emergency Preparedness and Response Authority (HERA). It would complement the initiatives put forward already by the Commission for the establishment of a stronger European Health Union: a revamped cross-border health threats legal framework, and extended and improved crisis related mandates for both the ECDC and the EMA. HERA will take a whole value chain approach, from threat assessment to conceptualisation to deployment in case of need. It will support Member States’ response capacities and access and ensuing availability and deployment of countermeasures to prepare for and address human cross-border health threats.

As noted, together with another important pillar of the Health Union, the Pharmaceutical Strategy for Europe, which aims to ensure the availability of safe and affordable medicines to patients across the EU, the future HERA will ensure a solid framework for EU preparedness, surveillance, risk assessment, early warning and response to all serious cross-border threats to health.

The inception impact assessment highlights the main objectives and tasks of the HERA, and identifies the three policy options on the new legislative proposal setting up HERA, which could combine the identified tasks with different degrees of regulatory involvement. Among the key tasks, the following can be noted:

- Development capacity - identifying and addressing market and regulatory challenges/failures and promote advanced research, innovation and development of corresponding technologies and countermeasures for anticipated cross-border threats to health (end stage research and development, clinical trials and investigations, testing and validation, data infrastructure, regulatory pathways and marketing authorizations, industry and private sector partnership engagement). The end function is to overcome industry development challenges to ensure that there are final public returns on prioritised policy areas in the field of medical countermeasures and when public funds have already been disbursed; - Production capacity - establishing EU flexible and scalable manufacturing capacities for the development of crisis-relevant countermeasures (including crisis relevant raw materials) adequate to respond to health emergencies; this capacity could be complemented by a mechanism for the monitoring and pooling of existing manufacturing and innovation capacities. This could be done in different ways, such as establishing manufacturing and innovation infrastructure or creating an access network for this purpose in line with the EU industrial strategy; - Distribution capacity and ensuring surge capacity at EU level via integrated EU stockpiling and distribution mechanisms; this would also include logistical infrastructure (for storage and distribution) and tailored emergency procurement and financial instruments. Duplication with existing instruments such as the EU’s Union Civil Protection Mechanism will be avoided. HERA

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would have all the legal and financial capacities to reserve access, procure and ensure distribution of medical countermeasures that are needed.

In parallel to the establishment process of HERA, preparatory actions will be launched, under the current and future EU financing programmes in the field of health. These actions will test a number of solutions that could serve as a blueprint for future HERA functions and provide indications on the added value of its interventions, and possible areas for improvement. The preparatory actions will focus on emerging biological threats to human health and antimicrobial resistance.

An impact assessment will accompany the legislative proposal that will be adopted towards the end of 2021. The impact assessment will provide a robust evidence base for the contents of the legal proposal and quantify, as far as possible, the costs and benefits of the options presented above.

HEALTH DATA

European Commission publication on EU Member States’ rules on health data in the light of GDPR

The European Commission has published a study on the Assessment of the EU Member States’ rules on health data in the light of GDPR (cf. https://ec.europa.eu/health/sites/health/files/ehealth/docs/ms_rules_health-data_en.pdf and https://ec.europa.eu/health/sites/health/files/ehealth/docs/ms_rules_health-data_annex_en.pdf).

There are several points in common with the reply that AESGP has submitted to the European Health Data Roadmap (see point 1.).

The study finds that while the General Data Protection Regulation (GDPR) lays down horizontal directly applicable rules in all Member States, there remains variation in the range of national- level legislation linked to its implementation in the area of health. This, the study suggests, has led to a fragmented approach in the way that health data processing for health and research is conducted in the Member States. This can negatively impact cross-border cooperation for care provision, healthcare system administration, public health or research.

To ensure that European healthcare systems can make the best possible use of health data and to support the development of the European Health Data Space, a number of legal and operational issues need to be addressed in a multi-faceted approach. The study identified potential future EU level actions, including stakeholder-driven Codes of Conduct as well as new targeted and sector-specific EU level legislation. In addition to legal requirements and governance, the study also points to the need for a more harmonised approach across the Member States when it comes to technical infrastructure, technical and semantic interoperability. Data quality and acquisition, digital skills and capacity-building for primary and secondary use of health data were also areas identified where a harmonised approach could be beneficial.

The study goes on to highlight that co-operation between the EU, Member States and relevant stakeholders is important, with a particular focus on the interests of patients. The study specifies that they should be supported as active agents in their own health and care, with full capacity to exercise their health data related rights.

In conclusion, the development of the European Health Data Space, including specific legislation to be adopted to complement the proposal for a Data Governance Act, is believed to offer the ideal opportunity to build upon the suggestions outlined in the study. In addition, it is believed to ensure that health data can be used to promote better patient care, more resilient healthcare systems and stronger collaborative public health protection and healthcare research across the European Union.

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Background

The objective of the study was to examine and present the EU Member States’ rules that govern the processing of health data in light of the GDPR. The aim was to highlight possible differences and identify elements that might affect the cross-border exchange of health data in the EU for healthcare or for research, innovation and policy-making, and examine the potential for EU level action to support health data use and re-use.

The study is based on a series of expert workshops, organised in the first half of 2020, with the participation of representatives from Ministries of Health, stakeholders’ representatives, Data Protection Authorities and independent experts online consultations among stakeholders across the EU, desk research and legal analysis carried out by national legal experts.

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