.png)
TL;DRA marketing authorisation (Zulassung) is the regulatory approval a finished medicinal product must hold before it may be placed on the market, granted by the competent authority only after an assessment of its quality, safety and efficacy. In Germany the legal basis is §21 AMG.
The principle behind §21 AMG is a prohibition with reservation of permission: a finished medicine may not be marketed unless it is authorised by the competent federal authority, or unless the European Union has granted a central authorisation for it. Without that approval, placing the product on the market is unlawful. This entry covers the authorisation itself and the four routes to obtain it. The identifier that the authorisation carries is the EU-Zulassungsnummer (marketing authorisation number), and the legal entity that holds it is the Zulassungsinhaber (marketing authorisation holder). Both are separate topics with their own entries.
An authorisation is not a formality. Under §25 AMG the competent authority may refuse it only on defined grounds: incomplete documentation, inadequate pharmaceutical quality, an unfavourable risk-benefit balance, or a failure to demonstrate therapeutic efficacy according to the current state of scientific knowledge. Read positively, those grounds are the three pillars every applicant must satisfy: quality, safety and efficacy. The authorisation is granted in writing, applies only to the specific medicine described in the decision, and is issued with an assignment number.
A marketing authorisation is not the same as a Registrierung. Homeopathic medicinal products are entered in a register under §38 AMG, where §38(1) states plainly that an authorisation is not required, and certain traditional herbal medicinal products follow a comparable registration route. A registration deliberately does not require the full efficacy evidence that §25 AMG demands for an authorisation, which is the substantive difference between the two.
A medicine can reach the market through one of four procedures. Which one applies depends on how many countries the applicant targets and whether the product falls under the mandatory scope of the centralised route.
| Procedure | Scope | Who grants it | Prior authorisation needed |
|---|---|---|---|
| National procedure | One member state | The national competent authority, in Germany the BfArM or the Paul-Ehrlich-Institut | No |
| Mutual recognition procedure (MRP) | Extends an existing national authorisation to further member states | Each concerned member state grants its own national authorisation | Yes, a national authorisation must already exist |
| Decentralised procedure (DCP) | Several member states at once | Each concerned member state grants its own national authorisation | No, the application is filed simultaneously |
| Centralised procedure | The whole EU plus Iceland, Liechtenstein and Norway | The European Commission, after EMA assessment | Not applicable, one single application |
The national procedure is the simplest: the applicant files with one authority for one country. The mutual recognition procedure and the decentralised procedure both produce a bundle of national authorisations across several member states, and they differ in one point only. MRP starts from an authorisation that already exists in one member state and asks the others to recognise it. DCP files in all the chosen member states at the same time, with no prior authorisation, one acting as reference member state for the common assessment. At the end of either, each participating country grants its own national authorisation, so the marketing authorisation number is national, not an EU/1 number.
The centralised procedure is different in kind. The applicant submits a single dossier to the European Medicines Agency, its committees run the scientific assessment, and the European Commission, not the EMA, grants one authorisation valid across all EU member states and the EEA states Iceland, Liechtenstein and Norway. That authorisation carries an EU/1 number.
For some categories the centralised route is compulsory. The mandatory scope includes:
Outside that mandatory scope, the centralised procedure is optional for other innovative medicines, while most generics and non-prescription products are assessed and authorised nationally.
Germany has two federal higher authorities for medicines. The BfArM authorises most human medicines. The Paul-Ehrlich-Institut is responsible for immunological medicinal products, that is vaccines, sera, allergens and blood products, as well as advanced therapy medicinal products and medicines derived from tissue. The European Commission, on EMA assessment, grants the centrally authorised products. Whichever body grants it, the authorisation is held by the marketing authorisation holder, covered in the Zulassungsinhaber entry.
A marketing authorisation is not open-ended in the way a patent is not. Under §31 AMG the authorisation expires five years after it is granted unless the holder applies for renewal at least nine months before that deadline. Once renewed, the authorisation is as a rule valid without a time limit, though the competent authority may, on pharmacovigilance grounds, require a single further five-year renewal instead of granting unlimited validity.
For professionals the operational question is rarely the legal theory. It is which of the four routes a given product took, who holds the authorisation, and in which country it is valid. Those facts sit on the article, reached from the PZN for a German pack or per product for a centrally authorised medicine.
For a concrete authorisation the best single source is the article's authorisation number and the linked SmPC (Fachinformation), where the procedure is visible in the number format and the holder is named in section 7.
One honest limitation: an aggregator shows how and by whom a product was authorised, but it is not the authorising authority. The legally binding statement of a medicine's current authorisation status is the register of the competent authority, the BfArM or the Paul-Ehrlich-Institut for national products and the EU Union Register for centrally authorised products. Where a decision turns on whether an authorisation is currently in force, that authority, not a database copy, is authoritative.
