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UNITED NATIONS E/NL. 1978/57-59 15 October 1981 ENGLISH ONLY LAWS AND REGULATIONS PROMULGATED TO GIVE EFFECT TO THE PROVISIONS OF THE INTERNATIONAL TREATIES ON NARCOTIC AND PSYCHOTROPIC SUBSTANCES

SPAIN Communicated by the Government of Spain

NOTE BY THE SECRETARY-GENERAL - In accordance with the relevant Articles of the International Treaties on Narcotic Drugs and Psychotropic Substances, the Secretary-General has the honour to communicate the following legislative texts.

INDEX

E/NL.1978/57 Order of 11 May 1977 concerning medical prescriptions ..

E/NL.1978/58 Decision of the Department of Health concerning the classification of proprietary medicines in accordance with the therapeutic index

E/NL.1978/59 Royal Decree No. 2829 of 6 October 1977 regulating psychotropic medicinal substances and preparations and the control and inspection of the manufacture, distribution, prescription and dispensing of such substances and preparations

E/NL.1978/57

Official Gazette No. 129 31 May 1977

MINISTRY OF THE INTERIOR

12918 ORDER of 11 May 1977 concerning medical prescriptions

Sir,

In viev of the appearance of new medicaments and of more modern therapeutic methods, it has become advisable to bring up to date the Order of this Ministry dated Ik August 1965 concerning the dispensing of medical preparations and proprietary medicines, with a view to ensuring maximum efficacy and health control in the use of medical preparations and proprietary medicines.

Accordingly, this Ministry has decided to mate the following Order:

1. "Medical prescription" means the document whereby a medical practitioner prescribes the to be administered to the patient and to be dispensed by a pharmacy.

2. Every prescribing medical practitioner shall enter the following particulars in his medical prescription forms:

(a) His surname and first names; (h) His full address and, if possible, telephone number, the place where he practises and, as appropriate, the address of the health institution with which he is professionally connected;

V.81 30528 - 2 -

(c) The province; ^/t^^s%ss;iacia^oh-to which he'bei0n&4 and'xtentoerbhip number.

If he does not have a membership number, he shall state the reason for the issue of the medical prescription.

2.1 If a medical practitioner uses a medical prescription form of a health institution, he shall enter the particulars specified in subparagraphs (a) and (c).

2.2 Every prescription shall bear the following instructions which may be printed on the back of the "form?"

"To - be; 1 used within i;en days- of the date of prescription."

"The" medicationpre*scribed'shall not be used for more than three months of treatment.11

"The prescription shall remain in the possession of the pharmacy."

3. For a prescription to be valid for the purpose of dispensing by a pharmacy, the prescribing medical practitioner shall, in addition to entering the particulars specified in paragraph 2 above", make the following entries (but no others):

(a) The name of the medicament or medicaments or ^p^ medicines, in legible handwriting, specifying in each, case the pharmaceutical formula^ the format, the dose per unit where there are more than one, and the number of packets to be dispensed. If the prescription is urgent, this fact shall' likewise ••be?,noted by the- medical practitioner. '

The same particulars are required in; the case of prescribed remediesi

(b) Signature and title of the prescribing medical practitioner and date of the prescription-.

k. If the medical practitioner considers it necessary to give instructions in writing to the patient on the use or administration of a medication these instructions may be written on a sheet that can be detached from the medical prescription form itself. On this separate sheet he shall enter the name and first names of the patient and other personal data as appropriate. ~ ••

5. The medication prescribed in each medical prescription shall not exceed the quantity, required for a three-month period of treatment, and consequently the pharmacy may not issue a larger quantity except' on the express:authority of the medical practitioner given in the prescription'made out by'him.

6. A medical, prescription, once filled, shall be retained by the pharmacy as evidence of the dispensing or for other purposes, as appropriate, and shall be recorded in the prescription book in the manner and in the cases specified by the Department of Health.

6.1 Notwithstanding the foregoing provisions, in the case of treatment for a long period, and subject to Observance of the provision in paragraph 5 concerning express authority, a prescription maty'be filled by-stage's.' In any such case, "the pharmacy must it amp etnd date it, indicating the quantity dispensed; if necessary,, the back of the prescription form may be used for this purpose and the form shall then be returned.

The pharmacy dispensing the final portion shall retain the medical prescription as :

required under, par-agraph .6. ,; . •,

6r2;'te^a-:iie^icral prescription form contains more than one prescription and the pharmacy is unable at the time to supply one of the medicaments or proprietary medicines " prescribed, the pharmacist shall enter on the form in writing particulars of the medication . - 3 -

he has dispensed, stamp the prescription form and return it to the patient. If the medicament or proprietary medicine is one which under these regulations may not he dispensed without a prescription, the pharmacy filling the prescription shall retain the form as required under paragraph 6.1..

6.3 If a pharmacy happens not to have in stock at the time any one or more of the medicaments or proprietary medicines mentioned in the prescription it may, after informing the person concerned,, dispense a medicament of another "brand, provided that the pharmaceutical formula, active principles, dosage and indications are the same as those prescribed. Exceptionally, a prescribed medicament may be replaced by one of like nature by a pharmacy on night or holiday duty in cases where the prescription is stated to be urgent.

The pharmacist shall in any such case as aforesaid write down on the prescription form the name of the medicaments or proprietary medicines dispensed in place of those prescribed, aid affix his signature thereto; 1

7. The period of validity for the beginning of the use of a prescription shall in any case expire ten days after the date of the prescription entered on the form pursuant to paragraph 3 (b).

8. A prescription on a medical prescription form shall be required, and must consequently be produced to the dispensing pharmacy, in respect of the medicaments and proprietary medicines which belong to the therapeutic groups mentioned in the Annex to this Order.

Nevertheless, the Department of Health may, on the report of the National Centre of Pharmacobiology and after such other consultations as it considers desirable, exempt from this requirement, or, conversely, impose it in respect of, a particular medicament or proprietary medicine if such action is advisable for technical and health reasons.

9. Laboratories manufacturing proprietary medicines shall print the words "By prescription" on the packet containing them, as well as the appropriate symbol, in cases where prescription in this form is mandatory in pursuance of the foregoing provisions.

10. The provisions of this Order shall be deemed not to affect those of the Order of 31 August 1935 if the medicaments or proprietary medicines in question are narcotic drugs.

TRANSITIONAL PROVISIONS

1. Laboratories shall be allowed a time-limit of one year from the date of entry into force of this'Order in which to comply with paragraph 9 in the case of proprietary medicines now on the market for which a medical prescription is not at. present required for the purpose of dispensing but which will in future be subject to this requirement under the new regulations.

2. Medical practitioners and, where appropriate, health institutions and agencies shall bring the format of their printed prescription forms into conformity with the rules laid down in this Order within one year from its entry into> force. Tte->time-:liimt/me^^-fbr^ good and sufficient reasons, be extended by the Department of Health. •

FINAL PROVISIONS

1. The Annex to this Order may be amended by decision of the Department of Health, acting On the report from the National Centre of Pharmacobiology. - U -

2. The Department of Health shall take the necessary measures for giving effect to this Order and settle any doubts that may arise.

3. The Order of ih August 19^5 and the Decision of the Department of Health dated 2 November 19&5 are hereby rescinded.

Madrid, 11 April 1977

MARTIN VILLA

To the Director-General of Health

ANNEX

List of the medieaments and proprietary medicines contained in them vhich may not, under paragraph 8, be dispensed by a pharmacy without a medical prescription:

(a) All injectable medicaments and proprietary medicines; (b) The medicaments and proprietary medicines to be administered otherwise than by injection included in the therapeutic groups and sub-groups of the "anatomical classification" set out below (anatomical classification and numbers established by the Under-Directorate General of Pharmacies on 19 May 1976 for the registration of proprietary medicines).

A. Digestive system and metabolism

A.2.B. Anti-peptic ulcer A.3.C. Gastrointestinal antispasmodics and anticholinergics combined with ataraxics A.3.D* Gastrointestinal antispasmodics -and anticholinergics combined with analgesics A.5.B. Lipotrophic hepatic protectors A.5.C. Cholagogues in lipotrophic combinations A.6.A.2. Drastic laxatives A.8.A. Non-dietary antiobesity products A.10. Antidiabetics A. 14.A. Hormonal anabolizers

B. Blood and hematopoietic organs

B. l. Anticoagulants B.2. Hemo&tatics (except locally applied) B.k» Hypocholesterinemizers and antiarteriosclerotics B. 6. Other hematological agents,, including fibrinolytics arid hyaluronidase, except topical

C. Cardiovascular system

C:l. Cardiotherapy C. 2- Hypotensors C.3* Diuretics C.k. Peripheral vasodilators, except for topical use C.5-A.1. Typical antihemorrhoidais with corticosteroids C. .5.C General vasoprotectors

D. Dermatological

D. l.A.2. General antimycotics D.6.. Antibiotics and topical sulfonamides D.7. Local corticosteroids, except non-absorbable - 5 -

G. Genito-urinary products and sex hormones

G.2.A. Oxytocics G.3. Sex hormones and genital stimulants G. U.A.I. Sulfonamides, specific and combined with antibiotics

H. Hormone preparations, general

J. Anti-infectious, general

M. Locomotor system

M.l. Anti-inflammatory and antirheumatical M.3. Muscle relaxants M.U Antipodagrics

N. Central nervous system

N.l.A. General anaesthetics N.l.B. Local anaesthetics, except those used topically N.2.A. Narcotic analgesics H. 3. Anti-epileptics N.U. Anti-Parkinson's disease N.5. Psycholeptical (anaphylatic, neuroleptic and tranquillizers) N.5.B. N.6. Psychoanaleptics (antidepressives, thymoanaleptics, psychostimulants) N.7« Others, including parasympathomimetics

P. Parasitosis

P.l. Antiparasitics

R. Respiratory system

R.l.A.l. Corticosteroids, unmixed R.l.A.3. Corticosteroids, with anti-infectious substances R.I.A.U. Non-corticosteroids with anti-infectious substances R.3.A. Anti-cough (narcotic) R.6. General .

S. Sense organs

S.l.A. Anti-infectious, antibiotic and sulfonamides S.l.B. Corticoids, unmixed S.l.C. Corticoids combined with anti-infectious substances 5.1. D. Others: anaesthetics, mydriatics, miotics 5.2. A. Anti-infectious: antibiotics and sulfonamides 5.2. B. Corticoids, unmixed S.-3.A. Anti-infectious: antibiotics and sulfonamides 5.3. B. Corticoids, unmixed S.3.C. Corticoids combined with anti-infectious substances

V. Miscellaneous

V.l. Allergens V.2. Cytostatics and immunosuppressive products V.U.A.. Radiological contrasts - 6 -

E/NL.1978/58

12919 DECISION of the Department of Health concerning the classification of proprietary medicines in accordance with the therapeutic index

In view of the modern standards for the anatomical classification of proprietary medicines, this Department of Health, by circular dated 19 May 1976, communicated to the pharmaceutical laboratories, through the National Association of Chemical Industries, the therapeutic index to which authorized proprietary medicines must conform and the index cards (model 5) to be submitted by those laboratories before final authorization can be given in respect of the proprietary medicines in question.

With a view to the unification of standards regarding the therapeutic classification, it is advisable to require laboratories to submit three model 5 cards in respect of each of the authorized proprietary medicines, in accordance with the said therapeutic index>

In connexion with the new therapeutic.classification, the list of proprietary medicines being marketed will be brought up to date in order to improve the classification of the pharmaceutical market.

Accordingly, the Department of Health has decided as follows:

1. Pharmaceutical laboratories shall submit to the Department of Health (Under-Directorate-General of Pharmaceutics, 5*+ General Mola) ah alphabetical list, in duplicate, of the proprietary medicines which they are authorized to manufacture and which are at present on the market, together with a separate list, in like form, of those not at present being marketed. A separate list shall be prepared of proprietary medicines for veterinary use.

2. They shall in addition submit three copies of cards according to the model 5 reproduced in Annex I, duly completed, indicating the formats, in respect exclusively of the proprietary medicines that are at present on the market.

3. A time limit of one month from the date of,the publication of this Decision in the Official Gazette is allowed for compliance with the foregoing provisions. Non-compliance with the directions given in this Decision shall constitute an offence punishable as provided in Decree No. 2h6k of 10 August 1963.

k. The National Association of Chemical Industries and the Associations, ofvPharmaceutical Laboratories are authorized to print the model 5 cards, copies of which can also be obtained by the laboratories from the offices of the Under-Directorate-General of Pharmaceutics, 5h General Mola, Madrid -6.

Madrid, 25 April 1977 Victor Arroyo Arroyo Director-General

Annex I (obverse Model 5 9370)

THERAPEUTIC INDEX PROVISIONAL REGISTRATION NO FINAL NO. NAME PHARMACEUTICAL FORMULA FORMATS (l) LABORATORY (l) Indicate price of each format (Reverse) FULL QUANTITATIVE FORMULA E/NL.1978/59

Official Gazette No. 2fh 16 November 1977

MINISTRY OF HEALTH AND SOCIAL SECURITY

27160 ROYAL DECREE No. 2829 of 6 October 1977 regulating psychotropic medicinal substances and preparations and the control and inspection of the manufacture, distribution, prescription and dispensing of such substances and preparations

In the Government's performance of its vital task of safeguarding public health, which it carries out through, the Ministry of Health and Social Security, great concern is shown for the adequate control of psychotropic substances. The reason is that the action of these substances produces effects that call for watchful supervision of the use to which they are put for therapeutic purposes, with particular reference to the prevention of the potential harm to health caused by the improper or undue use of psychotropic substances.

In conformity with these objectives, which are of equal concern to other nations, international measures were formulated and agreed upon in the Vienna Convention on Psychotropic Substances of 21 February 1971* to which our country is a party.

Accordingly, in the context of the considerations referred to and in keeping with the spirit and purposes of the said Convention, it is desirable to enact regulations which take adequately into account the various aspects and problems connected with the aforesaid substances, whether in their pure state or included in preparations (proprietary medicines and/or prescribed remedies).

In view of the foregoing, different conditions and rules are prescribed to govern the individuals and corporate bodies forming the whole cycle to be controlled in respect of psychotropic substances, beginning with their manufacture and including the preparation of proprietary medicines containing them, the distribution, prescription and dispensing of such medicines, and also with respect to the prospects and requirements for imports and exports thereof.

It is provided that the preparations referred to must be prescribed on medical prescription forms, giving the data and particulars required for the correct delivery and recording of the preparations dispensed.

By virtue of the foregoing, acting on the proposal of the Minister of Health and Social Security and after deliberation by the Council of Ministers at its meeting of 6 October 1977*

I HEREBY ORDER

I. General provisions

Article 1

1. The psychotropic substances which are referred to in Schedules I, II, III and IV of Annex 1, and the "List of Substances not included in the Schedules" in Annex 2, referred to in article 5, or which may in future be added to the Schedules or the List, as well as the preparations (proprietary medicines or prescribed remedies) containing them, shall be subject to the provisions of this Decree. - 8 -

2. Without prejudice to the provisions of the preceding paragraph, the Pharmaceutical Regulations Department (Direccion General de Ordenacion Farmaeeutica) shall, in case of doubt, decide whether a particular proprietary medicine should or should not "be deemed to he one of those subject to the provisions of this Decree and determine the measures for "bringing it within the scope of this Decree, in conformity with its provisions.

Article 2

1. The use, manufacture, import, export, transit, trade, distribution and possession . of the substances listed in Schedule I, as well as their inclusion in any preparation, are prohibited,, also for the purposes of the Contraband Act.

2. Nevertheless, if any of the substances in Schedule I are to be used for scientific purposes, specific and detailed application shall be made, in each case, to the Pharmaceutical Regulations Department which may, in its discretion, grant authorization for the purpose, prescribing the control procedures to be observed.

Article 3

1. A preparation or proprietary medicine containing substances listed in more than one of the Schedules II, III and IV shall be deemed to be subject to the conditions and requirements prescribed for the substances included in the Schedule to which the severest treatment is applied under this Decree.

Article h

1. The Pharmaceutical Regulations Department may, by order, amend the contents of the Schedule of active principles listed in Annex 2, as well as the format and particulars of the books and printed forms, models of which are also reproduced in annexes to this Decree.

2. The said Department shall take the appropriate measures and decisions for the establishment of the Register both of manufacturers and of distributors, pursuant to articles

6 and lkt respectively, and also for determining the status of proprietary medicines to be covered or not to be covered by the provisions of this Decree.

II. Psychotropic substances not included in the attached Schedules I, II, III and IV

Article 5

1. Psychotropic substances not listed in Schedules I, II, III or IV of Annex 1 but in the "List of Psychotropic Substances not included in the Schedules" set out in Annex 2 to this Decree, and preparations containing the substances last mentioned, shall be exempted from the rules of this Decree, except in so far as the provisions of articles 13 and l6 regarding markings and prescriptions are applicable to them.

III. Manufactures of substances

Article 6

1. Individuals or corporate bodies engaged, or intending to engage, in the manufacture of any of the substances included in Schedules II, III and IV of Annex 1, as well as the Technical Manager in charge, must, in order to continue or before they begin manufacturing, as the case may be, receive authorization to do so and have their names entered in a register to be established for this purpose in the appropriate pharmaceutical services of the Narcotic Drugs and Psychotropic Substances Control Office of the Pharmaceutical Regulations Department. The authorization referred to in this article shall not affect those for which the Ministry of Industry and Energy is responsible. - 9 -

Article 7

1. The said manufacturers shall keep an account hook itemizing incoming and outgoing deliveries and stocks of the psychotropic substances they prepare, import or export. The said book shall consist of pages numbered consecutively, in which the entries are to be made according to the model in Annex 3 to this Decree.

2. Before beginning to use the account book, the manufacturer concerned shall submit it to the Provincial Inspectorate of Pharmaceutics in order to have the flyleaf initialled and every page stamped.

3. No spaces or lines shall be left blank in the book or on any of its pages. A separate page for each substance prepared by the manufacturer shall be provided at the beginning of the book. If necessary, the number of every additional page on which entries are made shall be indicated at the foot of each page. Notes or entries for each substance shall be kept separate, in order that all incoming and outgoing deliveries and remaining stocks may be checked without risk of error, substance by substance. > Article 8

1. The aforesaid manufacturers may not supply psychotropic substances except to individuals or corporate bodies authorized to manufacture, use, trade in or export them in conformity with the provisions of this Decree. Any such supply shall take place against the receipt of a dated voucher given by whichever of those persons or bodies has requested the supply. A separate voucher shall be required in respect of each of the psychotropic substances supplied. The vouchers shall be kept for two years among the records of the manufacturer, who shall classify them in different files, one for each substance produced, in order that it may be possible to check that the entry regarding an outgoing delivery in the book referred to above and the supporting voucher correspond. The said vouchers shall be printed by the Pharmaceutical Regulations Department.

2. The manufacturer shall also keep records, classified according to psychotropic substances, in the manner and for the purpose set forth in paragraph 1 above, of the import licences or export authorizations as the case may be, granted by the Pharmaceutical Regulations Department under the provisions of article 10. These licences and authorizations shall likewise be kept for two years.

Article 9

Manufacturers shall be required to submit to the appropriate pharmaceutical services of the Drugs and Psychotropic Substances Control Office of the Pharmaceutical Regulations Department, through the Provincial Pharmaceutical Inspectorate concerned, an annual return in duplicate setting out in detail, in respect of each psychotropic substance, the incoming and outgoing deliveries of that substance during the year and the stocks of such substances as of 31 December of that year. The Provincial Pharmaceutical Inspectorate shall retain the duplicate and transmit the original to the above-mentioned services during the month of January next thereafter. The returns shall be made on the printed forms a model of which is reproduced in Annex k to this Decree.

The said manufacturers shall be subject to inspection by the central and provincial pharmaceutical services attached to the Pharmaceutical Regulations Department, independently of the inspections by other administrative agencies to which they may be subject. - 10 -

IV. Imports and exports of psychotropic substances and of proprietary medicines containing such substances

Article 10

1. The import or export of any of the psychotropic substances listed in Schedules II, III and IV of Annex 1 shall require the prior authorization of the Pharmaceutical Regulations Department.

2. Similarly, the import or export of proprietary medicines containing psychotropic substances listed in the said Schedules shall he subject to the prior authorization of the said Department, to be granted in accordance with the legislative requirements in force concerning imports and exports of proprietary medicines.

3. The Pharmaceutical Regulations Department shall issue instructions or take such measures as it considers appropriate in respect of the data or printed forms required for the processing of imports and exports of the aforesaid psychotropic substances and of the proprietary medicines containing such substances.

V. Pharmaceutical laboratories

Article 11

1. Laboratories shall keep two account books, in one of which shall be recorded incoming and outgoing deliveries and stocks of the substances listed in Schedules II, III and IV, and in the other those of the proprietary medicines prepared with any of these substances. Any medicines which, although containing one or more psychotropic substances, have been declared by the Pharmaceutical Regulations Department to.be exempt from the provisions of this Decree under article 1 (2) shall not, however, be recorded in the book. Without prejudice to the foregoing provision, laboratories shall be bound to produce to the Pharmaceutical Regulations Department, at its request, documentary evidence of the manufacture and disposal of the medicines concerned.

2. The format, initialling, stamping and maintenance of the book shall conform to the terms of article J. The entries in the pages of the register shall be as described in the models reproduced in Annexes 3 and 5 to this Decree.

3. So far as the returns are concerned which they are required to submit annually to the Pharmaceutical Regulations Department, the laboratories shall comply with the requirements laid down in article 9 of this Decree.

Article 12

Laboratories shall be subject to the provisions of paragraph A below as regards the substances listed in Schedules II, III or IV, and to the provisions of paragraph B as regards the proprietary medicines containing such substances.

A. Listed psychotropic substances

Laboratories alone may use these substances, whether for the manufacture of proprietary medicines in which they have rights of ownership, or for export or for sale or delivery to persons entitled to use them under this Decree, subject always to the production of the appro- riate vouchers or documents which are prescribed by this Decree and which shall likewise be kept among the records as provided in article 8. In like manner, the listed substances may be obtained by laboratories only from the aforementioned individuals or corporate bodies, or through imports, subject to compliance in each case with the regulations prescribed for the purpose and to the appropriate recording of the documentary evidence for such transactions. - 11 -

B. Proprietary medicines containing listed psychotropic substances o Laboratories shall only deliver these medicines to pharmacetitical stores or pharmacies against production of the appropriate voucher. They may also export the medicines in accordance with article 12. In either case, the documents relating to the outgoing deliveries shall be recorded in the manner prescribed in article 8. VI. Proprietary medicines

Article 13

Proprietary medicines containing any of the psychotropic substances and therefore subject, under article 1 (l), to the provisions of this Decree, shall carry a symbol in the upper right-hand corner of each main outer surface of the packet and on the leaflet. The symbol will permit immediate and easy identification of the nature of the contents.

If the psychotropic substance is one of those listed in Schedules II, III or IV of Annex 1, the symbol shall be a disc divided equally into black and white halves, and for proprietary medicines containing substances included in the Schedule in Annex 2, the symbol shall be a circle crossed by a vertical diametrical line. In either case the symbol shall conform to the model in Annex 6.

VII. Distributors

Article ik

Individuals or corporate bodies engaged or intending to engage in the trade in any of the substances listed in Schedules II, III and IV of the annex, as well as the Technical Manager in charge, must - unless previously authorized or registered for some other reason - in order to continue or before they begin trading, as the case may "be, receive authorization to do so and have their names entered in a register to be established for this purpose in the appropriate pharmaceutical services of the Narcotic Drugs and Psychotropics Control Offices of the Pharmaceutical Regulations Department.

Article 15

Distributors shall be subject to the provisions of paragraph A below as regards the substances listed in Schedules II, III or IV in Annex 1, and to the provisions of paragraph B as regards the proprietary medicines containing such substances.

A. Listed psychotropic substances

Distributors shall obtain these substances exclusively from any of the individuals or corporate bodies authorized under this Decree, or by means of imports. They shall deliver them exclusively to individuals or corporate bodies that are likewise authorized, or for purposes of export. These transactions shall be subject to the issue or receipt of the vouchers or of import or export licences, as prescribed in articles 8 and 10. The vouchers and permits shall be kept among the records, in accordance with the rules laid down in the said article 8. Distributors shall also keep the account book referred to in article 7, and that book shall be kept with due observance of the formalities prescribed in the said article 7 as well as those relating to the records of the documents in question.

B. Proprietary medicines containing listed psychotropic substances

Distributors and pharmacies authorized by the Pharmaceutical Regulations Department under the Order of 7 April 196U shall receive proprietary medicines only from those authorized to manufacture or trade in them under this Decree, or by means of imports. They shall - 12 -

deliver the said medicines only to those authorized, or by means of exports, against the issue or receipt of vouchers analogous to those mentioned in article 8, or under an import or export licence as prescribed in article 10. The distributors are not bound to keep an account book of proprietary medicines like that required to be kept by pharmaceutical laboratories, but records of the relevant documents shall be kept and classified according to medicine in order that satisfactory documentary evidence of the disposal, stocks and balances of every proprietary medicine can be produced at any time to the inspectors of pharmacies.

VIII. Pharmacies

Article l6

With respect to the substances listed in Schedules II, III and IV of Annex 1, pharmacies shall comply with the provisions of paragraph A of this article.

As regards proprietary medicines containing psychotropic substances listed in Schedules II, III and IV, or in the "List of psychotropic substances not included in the Schedules" referred to in article 5, pharmacies shall observe the rules of paragraphs B and C below and those laid down specifically for the dispensing of medicines in article IT and in the Ministerial Order of 11 May 1911.

A. Substances included in Schedules II, III and IV (Annex l)

Pharmacies shall obtain these substances only from individuals or corporate bodies authorized under this Decree and only upon production of the vouchers or import licences, as required under articles 8 and 10. The substances may be issued or dispensed only upon receipt of a request for a prescribed remedy made out on a medical prescription form as required in article 17 and in the Ministerial Order of 11 May 1977• Every transaction shall be recorded in the account book of narcotic drugs.

B. Proprietary medicines containing substances listed in Schedules II, III and IV (Annex

Pharmacies shall obtain these medicines only from individuals or corporate bodies authorized under this Decree, upon production of a voucher.

The medicines may be issued or dispensed only upon receipt of a medical prescription, as required under article 17 and the Ministerial Order of 11 May 1977.

An account book need not be kept, but entries shall be made in the prescription book, and the prescriptions shall be kept among the records and classified by groups, as in the case of the vouchers required for deliveries from stores under article 15, except in cases where it is not possible to keep such records.

C. Substances and proprietary medicines containing substances in the "List of Psychotropic Substances not included in Schedules II, III and IV" (Annex 2)

Vouchers or an account book shall not be necessary for the acquisition of such substances and medicines, but appropriate entries shall be made in the prescription book and a medical prescription shall be required for the dispensing thereof in accordance with the provisions of the Ministerial Order of 11 May 1977.

Article 17

1. A medical prescription on the appropriate form shall be required for preparations (proprietary medicines or prescribed remedies) containing substances in Schedules II, III and IV and in the "List of Substances not included in the Schedules" referred to in article 5. - 13 -

Prescriptions for preparations (proprietary medicines or prescribed remedies) containing substances listed in Schedules II, III and IV that are kept among the records in pharmacies shall continue to be so kept for a period of two years.

2. In addition to fulfilling the requirements of the Ministerial Order of 11 May 1977» preparations (proprietary medicines or prescribed remedies) containing substances listed in Schedules II, III and IV shall, when prescribed or dispensed, be subject to the following requirements governing medical prescriptions:

(a) In the case of prescribed remedies, a medical prescription shall not be valid for more than ten days' treatment. Accordingly, the pharmacist may not dispense a larger quantity, except on the express authority of the medical practitioner concerned given in the medical prescription itself.

Only one packet of a proprietary medicine may be dispensed per prescription.

(b) Substances listed in the Schedules may not be included with other preparations in the same medical prescription.

IX. Offences and penalties

Article 18

Any breach of the provisions of this Decree shall be deemed to constitute a minor offence, except in so far as it is defined as a serious or very serious offence.

Article 19

The following shall be deemed to constitute serious offences:

1. Repetition of a minor offence. 2. Failure to keep or prepare the books, reports, vouchers and other official documents for registering, controlling and trading in psychotropic substances and preparations, or to keep the records relating to them required under the provisions of this Decree. 3. Selling, supplying or acquiring psychotropic substances and preparations manufactured with these substances to or from individuals or corporate bodies not thereunto authorized under this Decree. h. Failure to place the prescribed marks or symbols and other data required inside or outside the packet. 5. Failure to inform the Pharmaceutical Regulations Department of, or to apply for its permission for, the removal of installations for the manufacturing and other activities of firms and establishments to which this Decree applies. 6. Importing or exporting substances and proprietary medicines covered by this Decree without obtaining the appropriate authorization required for such activities from the Pharmaceutical Regulations Department. 7. Prescribing and/or dispensing otherwise than by a medical prescription form, or by a prescription form which does not fulfil the conditions laid down in the Ministerial Order of 11 May 1977 and those laid down in this Decree.

Article 20

The following shall be deemed to constitute very serious offences:

1. Repetition of a serious offence. 2. Manufacturing, importing, exporting, acquiring, possessing, stocking, selling or supplying and distributing psychotropic substances and proprietary medicines containing such substances without being authorized to do so and registered under the provisions of this Decree. - 1U -

3. Failure to comply with the provisions of article 2 with respect to substances included in Schedule I. h. Any case where one of the serious offences referred to above has caused harm to public health.

Article 21

Minor offences shall be subject to the following penalties:

1. A caution.

2. Fines of 5,000 to 50,000 pesetas.

Article 22

Serious offences shall be subject to the following penalties:

1. Fines of 50,000 to 500,000 pesetas. 2. In the case of the serious offences referred to in article 19, paragraphs 3 and k, the manufacture, sale or supply of psychotropic substances may be ordered to be suspended for a period of two months to one year. 3. In addition to the penalties listed above, the commission of the serious offences referred to in article 19, paragraphs 3 and U, shall entail the withdrawal of existing stocks from the market by the laboratory concerned and, if the substances are psychotropic, their seizure.

Article 23

Very serious offences shall be subject to the following penalties:

1. A fine of 500,000 to 5 million pesetas.

Article 2k

The Pharmaceutical Regulations Department and the Ministry of Health and Social Security shall be responsible for imposing penalties on any individual or corporate body contravening the provisions of this Decree.

1. The Pharmaceutical Regulations Department shall impose penalties for minor and serious offences. 2. Penalties for very serious offences, in an amount not exceeding 1 million pesetas, shall be imposed by the Ministry of Health and Social Security; penalties in excess of that amount shall be ordered by the Council of Ministers.

Article 25

The procedure for imposing penalties shall conform to that provided for in the general legislation governing Administrative Procedure and shall be independent of those which may arise from other jurisdictions or courts.

Final provisions

1. The Ministry of Health and Social Security shall take any further measures necessary for giving effect to this Decree, in order that the individuals and corporate bodies affected by it may comply with its provisions.

Given in Madrid on 6 October 1977. JUAN CARLOS

ENRIQUE SANCHEZ DE LEON PEREZ Minister of Health and Social Security -15 -

ANNEX 1

Substances listed in the Schedules to the Convention on Psychotropic Substances, done at Vienna on 21 February 1971 (Official Gazette of 10 September 1976).

List of substances in Schedule I

1. DET

2. DMHP

3. DMT

U. (+)-LYSERGIDE LSD, LSD-25

5. mescaline

6. parahexyl

7- psilocine, psilotsin

8. PSILOCYBINE

9. STP, DOM

10.. tetrahydrpcannabinols, all. isomers.

List of substances in Schedule II

1. AMPHETAMINE

2. DEXAMPHETAMINE

3. METHAMPHETAMINE

k. METHYLPHENIDATE

5. PHENCYCLIDINE

6. PHENMETRAZINE

List of substances in Schedule III

1.

2.

3.

k.

5. - 16 -

International non-proprietary names Other non-proprietary or trivial names

List of substances in Schedule IV

1. AMFEPRAMONE

2.

3.

k.

5.

6.

7. METHYLFHENOBARBITAL

8.

9.

10. PIPRADROL

11. SPA

ANNEX 2

List of psychotropic substances not included in Schedules I, II, III and IV.

International non-proprietary names Other non-proprietary or trivial names

Acecarbromal —' Agac Compound of with N-acetyl glycinamide Aponeuron Eromazepam Sandoctal Carbocloral Chloralsalicylamide Chlorexadol Chlordi az epoxi de Chlorphent ermine

1/ Note by the Secretariat: International non-proprietary names of drugs are underlined. - IT -

International non-proprietary names Other non-proprietary or trivial names

Chlortermine Chlorazepate Clobenzorex Cyclopentabarbital Di chloralphenazone Dimebamate Ebubamate Ethylamphetamine Fenallymal Fenproporex Heptabarbital Hydroximeprobamate Mephent e rmine Methylpent anol Methylpent anolcarb amate Ortetamine Penthrichloral Phendimetrazine Phenglutarimide Phentermine Potassitim Tilidine - 18 -

ANNEX 3

(Model of a page from the account hook for psychotropic substances that must be kept by manufacturers, laboratories and storage depots in accordance vith articles T*l» 11.1 and 15A of the present Decree.)

From page number Page number

Psychotropic substance Base equivalent

Origin or Received Issued Balance Date destination (kg) (kg) (kg) Comments

Under origin give the following particulars:

(l) Manufacture (2) Imported from (3) Purchased from manufacturer {h) Returned by

Under destination give the following particulars:

(l) Supplied to (2) Exported to (3) For preparation of the corresponding proprietary medicine (U) Comments: Returned to, etc. - 19 -

ANNEX h

(Model of the annual return on psychotropic substances that manufacturers and laboratories must send in to the Department of Health under articles 9 and 11.3 of the present Decree.)

Return for the year ......

Annual return on psychotropic substances submitted by Mr

Pharmacist and Technical Director of (laboratory) *

As: Director

of (factory)

Technician

Registered at the Department of Health under number

Psychotropic substance ;.. Base equivalent

Stock on 31 December of preceding year (in kg)

Balance (kg) Deduct balance on 31 December Origin or Received Issued of preceding Date destination (kg) (kg) year Comments

Under origin give the following particulars:

(l) Manufacture (2) Imported from (3) Purchased from manufacturer (U) Returned by

Under destination give the following particulars:

(l) Supplied to (2) Exported to (3) For preparation of the corresponding proprietary medicine - 20 -

ANNEX 5

(Model of page from account book for proprietary medicines that must be kept by laboratories in accordance with article 11.1 of the present Decree.)

From page number

Proprietary medicine Register number Pharmaceutical form

Origin or Received Issued Balance Date destination (units) (units) (units) Comments

Under origin give the following particulars:

(l) Preparation (with consignment number) (2) Imported from (3) Returned by

Under destination give the following particulars:

(l) Supplied to (with consignment number) (2) Exported to

ANNEX 6

(fv'mbol to appear on the packaging material of proprietary medicines containing psychotropic 3 hstances in Schedules II, III and IV, or in the list of substances not included in those Schedules.)