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 DRUGS 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 medication 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.