Marketing Authorizations (MA) Validity and Renewal in EU – Interesting Facts

Marketing Authorizations (MA) Validity and Renewal in EU – Interesting Facts

A marketing authorisation is required before medicinal products can be marketed in the EU. A marketing authorisation granted by the European Commission is valid in all Member States (centralised marketing authorisation). A marketing authorisation granted by a National Competent Authority (“NCA”) in a Member State is valid only in that Member State (national marketing authorisation).

After a marketing authorisation has been granted, the holder of the authorisation shall inform the Agency of the dates of actual marketing of the medicinal product for human use in the Member States, taking into account the various presentations authorised.

The marketing authorisation holder shall notify the Agency if the product ceases to be placed on the market of a Member State, either temporarily or permanently. Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The marketing authorisation holder shall inform the Agency of the reasons for such action in accordance with Article 14b.

According to Article 14 of Regulation (EC) No 726/2004 and Article 24 of Directive 2001/83/EC the initial standard marketing authorisation is valid for five years. Such marketing authorisation may be renewed on the basis of a re-evaluation of the benefit-risk assessment. To this end, the MAH shall provide the Agency or the NCAs with a consolidated version of the file in respect of quality, safety and efficacy, at least 9 months before the marketing authorisation ceases to be valid. The start of the evaluation process by the CHMP, more precisely by an elected Rapporteur and Co-rapporteur, shall be the earliest starting date possible, and it can take up to 120 days of active time.

Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the Commission decides, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, to proceed with one additional five-year renewal.

Any authorisation which is not followed by the actual placing of the medicinal product for human use on the Community market within three years after authorisation shall cease to be valid.

When an authorised medicinal product previously placed on the market is no longer actually present on the market for three consecutive years, the authorisation shall cease to be valid.

The marketing authorisation holder shall notify the Agency forthwith of any action the holder takes to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action.

Reference:

1.           Regulation (EC) No 726/2004 Of The European Parliament And Of The Council ( of 31 March 2004) - Laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

2.         Directive 2001/83/EC Of The European Parliament And Of The Council (of 6 November 2001) -  On the Community code relating to medicinal products for human use.