8. Post-Approval

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1. Renewals (except for MA under exceptional circumstances)

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  • A new marketing authorisation is valid for five years. The MA may be renewed after five years on the basis of a re-evaluation of the benefit risk balance by the relevant authority.
  • The MA holder shall provide the relevant authority with a consolidated version of the file in respect of quality, safety and efficacy, including the evaluation of data contained in suspected adverse reactions reports and periodic safety update reports submitted, and information on all variations introduced since the MA was granted, at least nine months before expiry of the MA.
  • Once renewed, the MA is valid for an unlimited period, unless the relevant authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal. 
  • If within three years of receiving a MA the product is not marketed or, after marketing, is no longer actually present on the market for three consecutive years the MA shall cease to be valid.
    • MAs under exceptional circumstances granted under Article 14(8) of Regulation (EC) No 726/2004 are also valid for 5 years. However, continuation of the authorisation shall be linked to the annual reassessment of the conditions under which the MA was granted.
    • Conditional MAs granted under Article 14-a of Regulation (EC) No 726/2004 do not fall under the above provisions. They are valid for 1 year and should therefore be renewed annually.

Legal basis: Article 24 of Directive 2001/83/EC; article 14 of Regulation (EC) No 726/2004