Renewal of the marketing authorisation

Renewal of the marketing authorisation is the procedure by which the authority re-evaluates, at the end of an initial five-year period of validity, the benefit/risk balance of the medicinal product before extending the authorisation. It is provided for by Directive 2001/83/EC for national authorisations and by Regulation (EC) No 726/2004 for centralised authorisations. Once renewed, the authorisation is in principle valid for an unlimited period.

The renewal procedure

The holder files its application at least nine months before the authorisation expires. It provides a consolidated version of the quality, safety and efficacy dossier, incorporating all variations introduced since grant, together with a summary of pharmacovigilance data. The authority checks that the benefit/risk balance remains favourable in the light of all the data acquired. Where the application has been filed in time, the authorisation remains in force during the examination and the product may stay on the market.

Unlimited validity and its exceptions

After renewal, the authorisation is valid without limit of time. The authority may nevertheless decide, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients, to require one additional five-year renewal. Unlimited validity does not shield the authorisation from suspension, withdrawal or an imposed variation where new data so justify. It also remains subject to the sunset clause if the product is not actually marketed. Conditional authorisations, for their part, follow their own regime of annual renewal.

Renewal and protection

Renewal does not revive data protection, which runs from the initial authorisation. It does, however, ensure the continuity of the authorisation on which the supplementary protection certificate depends, as the certificate lapses when the authorisation on which it is based is withdrawn. Failure to renew in time may therefore have consequences that go beyond regulatory law and affect the protection conferred by the industrial property title.

Key points

The authorisation is granted for five years and then renewed after re-evaluation of the benefit/risk balance, in principle for an unlimited period. The application must be filed at least nine months before expiry. Renewal extends no regulatory protection, but it determines whether the authorisation on which the supplementary protection certificate rests is maintained. The five-year expiry date and the filing deadline should be entered in the product’s regulatory calendar, in the same way as the patent renewal fees.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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