Issues Related to Marketing Authorisation, Marketing Authorisation Procedures

MAH- As of the end of the transition period, a marketing authorisation holder established in the United Kingdom has to have transferred its marketing authorisation to a holder established in the EU. The transfer of the marketing authorisation must be fully completed and implemented by the marketing authorisation holder before the end of the transition period.

Reference medicinal product (generic or hybrid application) - for generic/hybrid applications marketing authorisations will be granted after the end of the transition period. Where the RefMP has been authorised before the end of the transition period, it has to be authorised in an EU Member States. Where the RefMP has been authorised after the end of the transition period, it has to be authorised in an EU Member States.

Bioequivalence studies- The applicant can submit an abridged application if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised in the EU for not less than eight years.

Well-established use- In this regard, the provisions of Annex I of Directive 2001/83/EC or Annex I of Directive 2001/82/EC are to apply. Data sourced from the United Kingdom before the end of the transition period can be taken into account to demonstrate that the active substances of a medicinal product in the claimed therapeutic indication and (for veterinary products) target species have been in well-established use within the EU for at least ten years, with recognised efficacy and an acceptable level of safety.

Global marketing authorisation (GMA) - The global marketing authorisation is accompanied only by a single regulatory data protection period which applies both to data relating to the original medicinal product and to data presented for any subsequent developments. Marketing authorisations granted before the end of the transition period by the United Kingdom are considered as the initial marketing authorisation in the EU. That regulatory data protection period begins with the grant of the initial marketing authorisation in the EU.

Minor Use Minor Species/limited market (veterinary medicinal products)- MUMS/limited market classification is connected to the product/indication and therefore transferable together with the product. The five-year period of validity for MUMS/limited market classification is not affected by the transfer of classification. For already authorised MUMS/limited market veterinary medicinal products it is important to note that a transfer of marketing authorisation does not include a transfer of a MUMS/limited designation.

Financial and administrative assistance in accordance with Commission Regulation (EC) No 2049/2005 (the ‘SME Regulation’)- In order to be eligible for financial and administrative assistance, companies must be established in the EU and meet the definition of an SME. As of the end of the transition period, the guidance for non-EU based companies applies also to UK based companies.

Sunset Clause- When an authorised product previously placed on the market in the authorising Member State or in the Union is no longer actually present on the market for a period of three consecutive years, the authorisation will cease to be valid. If after the end of the transition period, the medicinal product is not placed on any other market of the remaining Member States, the three year period for the sunset clause will start running from the last date the medicinal product was placed on the UK market before the end of the transition period.

CHMP scientific opinion for ancillary medicinal substances in medical devices assessed by UK notified bodies (medicinal products for human use)- As of the end of the transition period, UK notified bodies will lose their status as EU notified bodies. They will no longer be able to be an applicant in an initial consultation procedure with EMA and EMA will not be able to issue a scientific opinion to them as notified bodies of a third country.

Referral procedures ongoing at the end of the transition period-The fees for referrals is determined at the start date of procedure. For medicinal products for human use, the fees for Pharmacovigilance referrals is calculated based on products authorised in the EU (as recorded in 'Article 57 database) at that time.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en

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