National procedure: authorisation in a single Member State
A national procedure authorises a medicine in one EU Member State only, assessed by that country's competent authority under Directive 2001/83/EC.
Under Articles 6 and 8 of Directive 2001/83/EC a medicine may not be placed on the market in a Member State without an authorisation from its competent authority, and the national procedure is the route for obtaining one in a single country. The dossier follows the same Common Technical Document format as any other EU application, and the authority must complete its assessment within 210 days of a valid application under Article 17(1). The product information, labelling and leaflet are approved in the national language.
The route is open only to products outside the mandatory scope of the centralised procedure, and only where the applicant does not already hold, or seek, an authorisation for the same product in another Member State. Article 18 requires an authority that learns the same application is under examination elsewhere to decline and send the applicant to the mutual recognition procedure. A purely national authorisation is still common for old products, for local line extensions and for markets where the company has no wider plans. It is also the starting point of every later mutual recognition procedure, because the reference member state must hold a national authorisation first.
What goes wrong: a national dossier filed years ago that no longer meets current standards, which surfaces when the company tries to extend it through mutual recognition and the reference member state has to update its assessment report; national product information that has drifted from what the dossier supports; national requirements on packaging, Braille and local representatives that the applicant discovers late; and assuming that the 210-day limit is calendar time, when clock-stops for questions are added on top.
National procedures also mean national maintenance. Every variation, renewal and transfer is filed to the single authority on its own forms and fees, and a product authorised nationally in several countries, outside any mutual recognition link, needs separate submissions in each. Holders with such portfolios often run a harmonisation exercise before using the repeat-use procedure to add markets.
Under the new pharma package (not yet in force), national authorisations remain and become valid for an unlimited period by default, with variations filed electronically in EMA formats; see MA validity changes.
Timing
The authority has 210 days from a valid application to decide under Article 17(1) of Directive 2001/83/EC. Validation and any clock-stops for responses to questions come on top, so a year or more of calendar time is normal. Once granted, the authorisation is valid for five years and then, after one renewal, for an unlimited period unless the authority decides otherwise on pharmacovigilance grounds.
Used in
Before filing, compare a national filing with the decentralised and mutual recognition routes in the market expansion workflow.
Related terms
- MRP: mutual recognition procedureThe mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.
- DCP: decentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
- RMS: reference member stateThe reference member state (RMS) is the EU/EEA Member State that leads the assessment in a decentralised or mutual recognition procedure.
- Renewal: five-year re-evaluation of a marketing authorisationA renewal is the re-evaluation of a marketing authorisation's benefit-risk balance after its first five years, after which it is normally unlimited.
- MAA: marketing authorisation applicationA marketing authorisation application (MAA) is the dossier submitted to EMA or a national authority for permission to market a medicine in the EU.
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