COUNCIL OF EUROPE

COMMITTEE OF MINISTERS

________

RESOLUTION AP (99) 1

(superseding Resolution AP (95) 1)

The Representatives, on the Committee of Ministers, of Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom, member states of the Partial Agreement in the Social and Public Health field,

Recalling Resolution (59) 23 of 16 November 1959, concerning the extension of the activities of the Council of Europe in the social and cultural fields;

Having regard to Resolution (96) 35 of 2 October 1996, whereby they revised the structures of the Partial Agreement and resolved to continue, on the basis of revised rules replacing those set out in Resolution (59) 23, the activities hitherto carried out and developed by virtue of that resolution; these being in particular aimed at:

a. raising the level of health protection of consumers in its widest sense, including the making of a constant contribution to harmonising – in the field of products having a direct or indirect impact on the human food chain as well as in the field of pesticides, pharmaceuticals and cosmetics – legislation, regulations and practices governing, on the one hand, quality, efficiency and safety controls for products, and, on the other hand, the safe use of toxic or noxious products;

b. integrating people with disabilities into the community; defining – and contributing to the implementation at European level – of a model of coherent policy for people with disabilities, which takes account simultaneously of the principles of full citizenship and independent living; contributing to the elimination of barriers to people’s integration, whatever their nature, whether psychological, educational, family-related, cultural, social, professional, financial or architectural;

Having regard to the action carried out for several years for the purpose of harmonising their legislation in the public health field and, in particular, in the pharmacy sector;

Considering further that the lack of uniform laws on the supply of medicines restricted to medical prescription has created problems in the field of public health and still raises difficulties at international level;

Considering in particular that the tendency towards auto-medication and over-medication is increasing;

Believing that it is, therefore, increasingly necessary to achieve harmonisation of national laws in this field;

1. Recommend to the governments of the seventeen member states of the Partial Agreement that they restrict to medical prescription the supply of the medicines mentioned in the general provisions set out hereafter;

2. Invite the same governments to accept amendments which may be made later to the appendices ^{footnote 1} to this resolution by the Public Health Committee (CD-P-SP), which shall carry out an annual revision of these lists in the light of the general provisions set out hereafter.

1. The only substances affected by the recommended provisions are those used in human medicinal products.

2. Narcotic drugs are not referred to when they are already covered by special common provisions concerning the rules governing their supply.

3. This resolution does not apply to homeopathic preparations or to other similar non-allopathic minute dose preparations on the market in the member states. Sale and supply of these preparations are governed by legal provisions in force in each member state.

4. The lists of substances the presence of which in a medicinal product necessitates the delivery of a medical prescription are drawn up with reference to all the risks, direct or indirect, which they may represent to human health if they are utilised without medical supervision, even in a correct way, or if they are utilised in an incorrect way. In particular, the lists of medicinal products are drawn up according to:

a. their acute and chronic toxicity;

b. clinical experience in use (adverse reactions, tolerance, and so on);

c. their intended actions and uses.

Salts, esters and salts of ester are subject to the same classification as the substances themselves unless otherwise specified in the lists.

In cases where several substances are present in a preparation, the classification should take account of the phenomena of synergy (whether potentiating or not), antagonism or changes in the effects of the components.

5. A medicine may not be supplied except on a medical prescription when one or more of the following conditions apply:

a. it contains an active principle not previously used for medical purposes and, in particular, a new chemical molecule. In such cases, a revision of any restrictions shall be carried out within a period of not less than three years from the first date of marketing authorisation in one of the member states of the Partial Agreement ;

b. it is used parenterally ^{footnote 2} ;

c. it contains one or more substances in List I or II ^{footnote 3} in Appendix I hereafter, to which the following criteria apply:

The supply of a medicine containing one of the substances in this list may only be repeated if the prescriber so specifies on the prescription.

The supply of a medicine containing one of the substances in this list may be repeated without the prescribers having so specified, provided that they did not explicitly forbid such repetition and that the amount supplied at renewals (and their frequency) be consistent with the

medical and pharmaceutical data (such as the prescribed daily dose, the duration of treatment, the degree of medical supervision required by the condition, and so on).

For certain substances, exemptions from the "prescription only" requirement may appear in Lists I and II:

- in respect of low dosage or concentration and/or therapeutic indications;

- according to the route of administration and the composition of the medicine;

- according to the total container content.

a. List I:

- substances intended for conditions calling for short-term treatment and/or for which continuous medical supervision is necessary, either because of potential side-effects or to check the efficacy of treatment;

- substances administered for diagnostic purposes;

- substances with a new pharmacological mechanism of action;

b. List II:

substances intended for conditions for which the patient may continue the regular or intermittent treatment without a new medical advice, and for which well-known side effects do not call for frequent clinical examination.

1. Minimum requirements

The classifications shown are to be considered as minimum requirements; consequently, governments are free to apply stricter rules in any given case.

2. Classification of substances under special study

The substances on which further information is requested, or consultation with interested parties is pending, are marked appropriately.

3. Nomenclature

Wherever possible, the nomenclature used is that of the International Non-Proprietary Names (INN) of the World Health Organisation.

4. Revisions

Annual revisions will deal with:

- classification of new substances entering into the composition of medicinal products newly registered in the member states of the Partial Agreement ;

- classification of substances referred to in article 2 of this preamble;

- proposals for adding or deleting substances;

- proposals for adding or deleting derogations;

- proposals for amending exemption conditions.

Proposals for revision will be submitted by 1 January of each year in order to be examined by the competent bodies before 1 July. In cases of urgency, proposals for revision may be submitted at any time.

5. Date of adoption

The published list will indicate in each case the year of adoption by the Partial Agreement Public Health Committee.

1        Appendix I: Alphabetical list of substances.

Appendix II: Anatomic-therapeutic-chemical (ATC) classification of substances in the alphabetical list in Appendix I.

3    The differentiation in the two lists applies only to the countries which divide prescription medicines into two categories based on whether or not the prescription may be repeated.