About
Since 1965, a score of Community directives have been adopted with the aim of achieving a single, EU-wide market for pharmaceuticals. This single market should help not only to enhance the quality of life of European citizens, but also strengthen the European pharmaceutical industry’s competitiveness and research capability, for generations to come.

From the first European Community pharmaceutical directive, issued in 1965, Directive 65/65/EEC (1) to our days, Community lawmakers have striven to ensure that, first and foremost, medicinal products for human use help maintain a high level of protection for public health.

A decade later, two Directives, 75/318/EEC ( 2) and 75/319/EEC ( 3), sought to bring the benefits of innovative pharmaceuticals to patients across the European Community, by introducing a procedure for the mutual recognition, by Member States, of their respective national marketing authorisations. To facilitate mutual recognition, Directive 75/319/EEC set up a Committee for Proprietary Medicinal Products (CPMP), which first assessed whether candidate products complied with Directive 65/65/EEC. Subsequent problems in implementing the pharmaceutical directives were examined by the Pharmaceutical Committee, set up by Directive 75/320/EEC. By seeking to ensure the free movement of medicinal products throughout the Community, in line with Treaty provisions on the free movement of goods, these two directives marked the first step towards creating a Community-wide single market in pharmaceuticals.

The pharmaceutical lawmakers began after 1985 to turn the attention to pharmaceutical manufacturing and innovation as an economic activity. Council Directive 89/105/EEC (4) gives pharmaceutical companies assurances as to the transparency of the procedures used to control pharmaceutical prices, profits and reimbursement, whilst Council Regulation EEC/1768/92 (5) allows patent duration to be extended, so as to offset patent protection time taken up by marketing authorisation procedures.

To promote a rational use of medicines, the Council adopted four directives in 1992 on the wholesale distribution, classification for supply, labelling and package leaflets, and advertising of medicinal products for human use. Council Directive 92/27/EEC (6), on labelling and package leaflets, benefits the patient by requiring that all information identifying the product be stated on the outer packaging. A package leaflet must also be included inside the packet unless all the information to be given in the leaflet is already conveyed on the outer or immediate packaging. Council Directive 92/28/EEC, on advertising, distinguishes between medicines that are available over the counter, most of which may be advertised to the general public, and prescription-only medicines which may be advertised only to health professionals. Member States are required to prohibit the advertising to the general public of medicinal products that are available on prescription only, or which contain psychotropic or narcotic substances.

A new European system for the authorisation of medicinal products is currently in place since January 1995 with the adoption of Council Regulation 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (EMEA) (7) and of Directives 93/39EEC and 93/40/EEC (8).

The new European system offers two routes for authorising medicinal products:

A “centralised procedure”, with applications made directly to the EMEA, leading to the grant of a European marketing authorisation by the Commission. Use of this procedure is compulsory for products derived from biotechnology, and optional for other innovative products. The procedure results in a Commission decision, which is binding on all EU Member States, to authorise the product. Centrally-authorised products may be marketed in all Member States.

A “mutual recognition procedure”, which is applicable to the majority of conventional medicinal products. Applications are made to the Member States selected by the applicant and the procedure operates by mutual recognition of national marketing authorisations. Where this is not possible, the EMEA is called upon to prepare a binding arbitration. Purely national authorisations are still available for medicinal products to be marketed in one Member State.

With the exception of Council Regulation 2309/93 which regulates the “centralised procedures”, the directives governing the marketing authorisation granted by the competent authorities of the Member States have been frequently and sometimes substantially amended. In the interest of clarity and rationality, these directives were therefore codified by assembling them in two single texts, one covering the medicinal products for human use and one covering the veterinary medicinal products. The Council and European Parliament adopted in November 2001, two directives, Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary medicinal products and Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use.

The present CD Rom includes the volumes containing the different provisions applicable to medicinal products in the European Union. These provisions may consist of:

binding legislation (regulations and directives) (volumes 1 and 5);

a notice to applicants for marketing authorisation explaining the administrative procedures to be followed and the format of the application file (volumes 2 and 6);

a notice to applicants and note for guidance on the establishment of maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin (volume 8)

detailed guides to good manufacturing practice and pharmacovigilance (volumes 4 and 9).

(1) OJ No 22, 9. 2 1965, p. 369-373.

(2) OJ No L 147, 9. 6. 1975, p. 1-12.

(3) OJ No L 147, 9. 6. 1975, p. 13-22.

(4) OJ No L 40, 11. 2. 1989, p. 8-11.

(5) OJ No L 182, 2. 7. 1992, p. 1-5.

(6) OJ No L 113, 30. 4. 1992, p. 8-12

(7) OJ No L 214, 24/08/1993 p. 0001-0021.

(8) OJ No L 214, 24/08/1993.