The approval to market a medicinal product is based on the evaluation of scientific data provided by the company to support its quality, safety and efficacy. However, most of the 'new' products which come onto the market contain drugs which have been previously well tested and approved in other forms or for other companies. In these circumstances the European Directives (in particular Directive 2001/83EC) allow for what are known as 'abridged' applications so that companies do not have to unnecessarily repeat the tests and trials on animals and humans.
- The information given in this section refers to medicinal products containing chemical active ingredients. For information on abridged applications for vaccines and other biological products see the Biological and biotechnology products section.
- In the examples described below, the relevant sub-sections of the European Directive articles are shown in brackets. Note however that the advice on these pages has no legal basis and applicants are advised to refer to the original Directives and Commission guidance for a definitive view of their particular case.
If the new product meets requirements for a generic product defined in Article 10 (2)b of the Directive (2001/83 (as amended)), then it can be authorised without its own clinical and pre-clinical testing data.
The data requirements and the assessment process aim to ensure that patients could be switched between the brand leader product and a generic version without causing any therapeutic problems.
Existing drugs with new forms, routes and indications
Sometimes, although the drug is the same, the new product has a different strength or pharmaceutical form or is used by a different route or for different clinical uses. In these cases the company can submit more pre-clinical and clinical data to supplement their abridged application. (The 'Notice to Applicants' refers to these as 'other abridged' applications. The relevant legal basis is Article 10(3) of Directive 2001/83/EC). The full text of the Notice to Applicants is available on The European Commission - Enterprise DG - Pharmaceuticals and Cosmetics website.
Existing drugs in new combinations
New combinations of existing drugs may also be proposed though they may need a full data package to support them. (Article 10b)
'Well-established' drugs and products
The new product may include a drug substance which has such a well-established medicinal use and an acceptable level of safety that the applicant company can submit published data to support the safety and efficacy aspects of their application. (Article 10a) Examples here may include some over-the-counter (OTC) remedies.
Informed consent and change of ownership applications
For commercial reasons companies may want to take over or duplicate a product licence held by another company. Where the first company agrees to this 'informed consent' approach, the second company can get an exact copy licence commonly known as a 'piggy-back' licence. (Article 10c). Alternatively, where the ownership of the company changes hands and the new owners need to take over the old product licences. These applications are called 'change of ownership' applications.
Better Regulation of Medicines Initiative (BROMI): National informed consent (Article 10c, 'simple abridged') applications
The process for approval of national informed consent (Article 10c, ‘simple abridged applications’) has been reviewed within the Better Regulation of Medicines Initiative (BROMI) and a checklist has been devised to improve the quality of applications. Further information is available in the 'BROMI section':
› BROMI: National informed consent (Article10c, 'simple abridged') applications