Directive 2001/83/EC relating to medicinal products for human use
This Directive establishes a Community code which brings together all the provisions governing the placing on the market, production, labelling, classification, distribution and advertising of medicinal products for human use.
The code applies to all medicinal products for human use, except for:
- Medicinal products prepared in a pharmacy in accordance with a medical prescription (‘magistral formula’);
- Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia (‘officinal formula’);
- Medicinal products intended for research and development trials;
- Intermediate products intended for further processing;
- Radionuclides in the form of sealed sources;
- Whole blood, plasma or blood cells of human origin.
Manufacture and importation
The following operations are subject to authorisation by the Member States:
- Manufacture, dividing up, packaging or presentation of medicinal products within the territories of the Member States (with the exception of operations performed by a pharmacist solely for retail supply);
- All imports of medicinal products from Non-EU Member Countries.
Marketing authorization procedure
No medicinal product (with the exception, under certain conditions, of radiopharmaceuticals prepared at the time of use) may be placed on the market of a Member State unless an authorisation has been issued by the competent authorities of that Member State or by the European Medicines Agency (the ‘Agency’).
Only applicants established in the Community may be granted a marketing authorisation.
Certain particulars and documents must be included with the authorisation request, including :
- The name and constituents of the medicinal product.
- The manufacturing method.
- Therapeutic indications, contra-indications and side-effects.
- method and route of administration.
- Expected shelf-life.
- Precautionary and safety measures during storage and administration of the medicinal product and disposal of waste.
- The risk to the environment.
- A description of control tests employed by the manufacturer.
- The results of pharmaceutical, pre-clinical and clinical tests, and
- A copy of any marketing authorization obtained in another Member State or non-member country.