Definition
Medicinal products for human use designates any substance or compound presented as having curative or preventive properties with respect to human diseases, as well as any substance or compound that can be used in people or administered to people, for establishing a medical diagnosis or for restoring, correcting or modifying their physiological functions by exercising a pharmacological, immunological or metabolic action.
Medicinal products may take several forms: tablet, drinkable solution, injectable solution, etc.
Narcotic substances or psychotropics have additional constraints.
The handling of medicinal products for human use must be distinguished from that for medicinal products for animals.
Obligations and controls
In order to fight against the release for circulation of counterfeit medicinal products, the trade of medicinal products is strictly monitored.
The Pharmacy and Medication Department insures that, in Luxembourg, are distributed only those medicinal products for which a Marketing Authorization (MA) has been issued in compliance with Community law. It controls the persons authorized to exercise the wholesale trade of medicinal products and inspects their premises.
Note: a marketing authorization is granted either at the national level or by the Eupopean Medicines Agency. In the latter case it is valid throughout the European Union (EU).
A medicinal product with a marketing authorization may circulate freely within the EU.
The transport, storage and handling of medicinal products for human and veterinary uses are subject to strict rules that are called Good Distribution Practices (GDP). These practices must be carried out in appropriate conditions defined in the marketing authorizations or other specifications directly related to the products in question.
European regulations define the good distribution practices for the wholesale distribution of medicinal products for human use, in particular the conditions of temperature and storage during transport, as well as the rules governing packaging and labeling.
The only organizations that are allowed to carry out the activities described above are the following:
- holders of Manufacture and Import Authorizations (MIA)
- holders of wholesale trade authorizations of medicinal products
- holders of certificates of good distribution practices.
A company that exports medicinal products must hold a wholesale distribution authorization or a manufacture authorization. These medicinal products do not however need a marketing authorization under European law but the exporter must comply with the legal provisions of the destination country.
A company that manufactures medicinal products must have a manufacture authorization even if the product is manufactured for export.
A company that imports a medicinal product from a third country must have a manufacture and import authorization.
To deliver a manufacture and import authorization, the Pharmacy and Medication Department carries out inspections to verify the compliance with Good Manufacturing Practices (GMP) and, in the case of importing from a third country, a compliant batch release according to the same principles. A manufacture and import authorization can then be delivered by the Ministry of Health.
Related documents
The company in charge of the transport, storage, handling of medicinal products for human use must possess a manufacture and import authorization, a wholesale trade authorization or a certificate of good distribution practices delivered by the Luxembourg Ministry or a competent national authority in other countries.
Related organizations
In Luxembourg, the Pharmacy and Medication Department of the National Health Directorate has authority over questions related to medicinal and pharmaceutical products. It controls the manufacturing, marketing, advertising, distribution, import and export of these products.
The Pharmacy and Medication Department carries out inspections to make sure that the distribution sites are compliant with the requirements of good practices. Certificates of good distribution practices and wholesale trade authorizations are delivered as appropriate by the Ministry of Health.