Article 1 
1. This Directive concerns the classification for the supply of medicinal products for human use in the Community into: - medicinal products subject to medical prescription, - medicinal products not subject to medical prescription. 2. For the purposes of this Directive, the definition of 'medicinal product' in Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(5) as last amended by Directive 89/343/EEC(6) , shall apply. In addition, 'medicinal prescription' shall mean any prescription issued by a professional person qualified to prescribe medicinal products. Article 2 1. When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into: - a medicinal product subject to medical prescription, - a medicinal product not subject to medical prescription. To this end, the criteria laid down in Article 3 (1) shall apply. 2. The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification: (a) medicinal products on renewable or non-renewable medical prescription; (b) medicinal products subject to special medical prescription; (c) medicinal products on restricted medical prescription, reserved for use in certain specialized areas. Article 3 1. Medicinal products shall be subject to medical prescription where they: - are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or - are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or - contain substances or preparations thereof the activity and/or side effects of which require further investigation, or - are normally prescribed by a doctor to be administered parenterally. 2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors: - the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force (United Nations Conventions of 1961 and 1971), or - the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or - the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to that group as a precautionary measure. 3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: - the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment, - the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or - the medicinal product is intended for outpatients but its use may produce very serious side-effects requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 4. A competent authority may waive application of paragraphs 1, 2 and 3 having regard to: (a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or (b) other circumstances of use which it has specified. 5. If a competent authority does not designate medicinal products into sub-categories referred to in Article 2 (2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine. Article 4 Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 3. Article 5 1. The competent authorities shall draw up a list of the medicinal products subject on their territory to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. 2. On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 3. Article 6 1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 2 
1. When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into: - a medicinal product subject to medical prescription, - a medicinal product not subject to medical prescription. To this end, the criteria laid down in Article 3 (1) shall apply. 2. The competent authorities may fix sub-categories for medicinal products which are available on medical prescription only. In that case, they shall refer to the following classification: (a) medicinal products on renewable or non-renewable medical prescription; (b) medicinal products subject to special medical prescription; (c) medicinal products on restricted medical prescription, reserved for use in certain specialized areas. Article 3 1. Medicinal products shall be subject to medical prescription where they: - are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or - are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or - contain substances or preparations thereof the activity and/or side effects of which require further investigation, or - are normally prescribed by a doctor to be administered parenterally. 2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors: - the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force (United Nations Conventions of 1961 and 1971), or - the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or - the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to that group as a precautionary measure. 3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: - the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment, - the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or - the medicinal product is intended for outpatients but its use may produce very serious side-effects requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 4. A competent authority may waive application of paragraphs 1, 2 and 3 having regard to: (a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or (b) other circumstances of use which it has specified. 5. If a competent authority does not designate medicinal products into sub-categories referred to in Article 2 (2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine. Article 4 Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 3. Article 5 1. The competent authorities shall draw up a list of the medicinal products subject on their territory to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. 2. On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 3. Article 6 1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 3 
1. Medicinal products shall be subject to medical prescription where they: - are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or - are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or - contain substances or preparations thereof the activity and/or side effects of which require further investigation, or - are normally prescribed by a doctor to be administered parenterally. 2. Where Member States provide for the sub-category of medicinal products subject to special medical prescription, they shall take account of the following factors: - the medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force (United Nations Conventions of 1961 and 1971), or - the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, or - the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to that group as a precautionary measure. 3. Where Member States provide for the sub-category of medicinal products subject to restricted prescription, they shall take account of the following factors: - the medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment, - the medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere, or - the medicinal product is intended for outpatients but its use may produce very serious side-effects requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment. 4. A competent authority may waive application of paragraphs 1, 2 and 3 having regard to: (a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and/or (b) other circumstances of use which it has specified. 5. If a competent authority does not designate medicinal products into sub-categories referred to in Article 2 (2), it shall nevertheless take into account the criteria referred to in paragraphs 2 and 3 of this Article in determining whether any medicinal product shall be classified as a prescription-only medicine. Article 4 Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 3. Article 5 1. The competent authorities shall draw up a list of the medicinal products subject on their territory to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. 2. On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 3. Article 6 1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 4 
Medicinal products not subject to prescription shall be those which do not meet the criteria listed in Article 3. Article 5 1. The competent authorities shall draw up a list of the medicinal products subject on their territory to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. 2. On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 3. Article 6 1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 5 
1. The competent authorities shall draw up a list of the medicinal products subject on their territory to medical prescription, specifying, if necessary, the category of classification. They shall update this list annually. 2. On the occasion of the five-yearly renewal of the marketing authorization or when new facts are brought to their notice, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product, by applying the criteria listed in Article 3. Article 6 1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 6 
1. Within two years of adoption of this Directive, the Member States shall communicate the list referred to in Article 5 (1) to the Commission and to the other Member States, when requested by the latter. 2. Each year, Member States shall communicate to the Commission and to the other Member States the changes that have been made to the list referred to in paragraph 1. 3. Within four years of the adoption of this Directive, the Commission shall submit a report to the Council on the application of this Directive. This report will be accompanied, if necessary, by appropriate proposals. Article 7 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 7 
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall forthwith inform the Comission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. Article 8 This Directive is addressed to the Member States. Done at Brussels, 31 March 1992. For the Council The President Vitor MARTINS (1) OJ No C 58, 8. 3. 1990, p. 18. (2) OJ No C 183, 15. 7. 1991, p. 178 and OJ No C 67, 16. 3. 1992. (3) OJ No C 225, 10. 9. 1990, p. 21. (4) See page 13 of this Official Journal. (5) OJ No 22, 9. 6. 1965, p. 369/65. (6) OJ No L 142, 25. 5. 1989, p. 14.
Article 8 
This Directive is addressed to the Member States. Done at Brussels, 31 March 1992