8/9 December 2020
GMP News No. 328
18 July 2003
Commission Directive 2003/63/EC: The New Annex 1 to Directive 2001/83/ EC
Annex I to Directive 2001/83/EC (1) has been replaced by the text in the Annex to the new Commission Directive 2003/63/EC (2) that was published in the Official Journal L 159 of 27 June 2003.
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 Standardised Marketing Authorisation Dossier Requirements
Part I describes presentation requirements for standard applications and is adapted to the format and terminology of the harmonised CTD (Modules 1 to 5):
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 Specific Marketing Authorisation Dossiers and Requirements
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 Particular Medicinal Products
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 Advanced Therapy Medicinal Products
Part IV describes special dossier presentations for advanced therapy medicinal products like gene therapy products and somatic cell therapy medicinal products.
Please find the web addresses of the referenced documents listed below: