Annex I to Directive 2001/83/EC describes detailed scientific and technical requirements for the presentation and content of the marketing authorisation application dossier for human medicinal products and had to be adapted to the harmonised format and terminology of the Common Technical Document (CTD) in order to implement the Common Technical Document without delay.

The new Directive 2003/63/EC – and with it the new Annex I - is applicable from 1 July 2003. Member States are urged to bring into force laws, regulations and administrative provisions necessary to comply with this Directive by 31 October 2003 at the latest.

The standardised marketing authorisation dossier requirements should be applicable to any type of medicinal products for human use and to any procedure for granting the marketing authorisation (national, decentralised or centralised procedure). However, some medicinal products have such specific features that not all requirements can be fulfilled – or specific requirements are necessary.

To take this into account, Annex I is divided into 4 different parts:

Part I describes presentation requirements for standard applications and is adapted to the format and terminology of the harmonised CTD (Modules 1 to 5):

• Module 1: Administrative information
• Module 2: Summaries
• Module 3: Chemical pharmaceutical and biological information for medicinal products containing chemical and/or biological active substances
• Module 4: Non-clinical reports
• Module 5: Clinical study reports

Nevertheless, you can find some 'disharmonies' in the terminology when comparing Annex I to Directive 2003/63/EC with the CTD. For example, 'Drug Substance' as mentioned in the CTD is called 'Active Substance' in Annex I, 'Drug Product' as mentioned in the CTD is called 'Finished Medicinal Product' in Annex I. In order to avoid any confusion, it would have been much desirable if the harmonised CTD terminology had been used in Annex I as a whole.

Parts II, III and IV refer to those medicinal products that require simplified or specific dossier presentations.

Part II describes simplified dossier presentations for 'specific applications,' e.g. for medicinal products that contain drug substances of well-established medicinal use.

Part III deals with particular requirements for biological medicinal products like plasma-derived medicinal products, vaccines, radio-pharmaceuticals, homeopathic medicinal products, herbal medicinal products and orphan drugs.

Part IV describes special dossier presentations for advanced therapy medicinal products like gene therapy products and somatic cell therapy medicinal products.

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use