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1. ISSUES RELATED TO MARKETING AUTHORISATIONS, MARKETING AUTHORISATION PROCEDURES

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

1.1. Can medicinal products intended for use in COVID-19 patients be marketed in the absence of a marketing authorisation?

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). Procedures exist to facilitate the granting of national marketing authorisations of medicinal products that are authorised in another EU/EEA Member State.1

1 Mutual recognition procedure (“MRP”) and decentralised procedure (“DCP”) established by Directive 2001/83/EC.

The coordination group established under Article 27 of Directive 2001/83/EC (CMDh) has agreed to promote the use of zero-day mutual recognition procedure/repeat use procedure to expand national marketing authorisations to new Member States who need these medicinal products.

Member States may also authorise a medicinal product that has already been authorised in another EU Member State in accordance with Article 126a of Directive 2001/83/EC.

In cases where no centralised/relevant national marketing authorisation exists, Member States can make use of possibilities foreseen in Directive 2001/83/EC, including resorting to compassionate use, or authorisation of the distribution of an unauthorised medicinal product in accordance with Article 5(2) of Directive 2001/83/EC.

To permit prompt assessment of these requests, applicants are requested to identify any such communication to the relevant NCA with the message “CONCERNS COVID-19”.

1.2. Can I postpone my renewal application?

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.

MAHs facing difficulties to meet this deadline due to exceptional circumstances arising from the COVID pandemic, are invited to contact the EMA (for centrally authorised products) or the reference Member State (for products authorised under the MRP/DCP) before the foreseen deadline of the submission of the renewal application with a justified request to postpone the submission of the complete dossier to a later point in time.

The reference Member State will consult with the concerned Member State(s) and advice the MAH on any further step to be taken before the foreseen deadline. In case of purely national marketing authorisations, the relevant national competent authority should be contacted.

The same considerations apply to conditional marketing authorisations granted in accordance with Article 14-a of Regulation (EC) No 726/2004.

1.3. Does the ‘sunset clause’ apply during a pandemic?

According to Article 24(4) to (6) of Directive 2001/83/EC and Articles 14(4) to (6) of Regulation (EC) No 726/2004, any authorisation which within three years of its granting is not followed by the actual placing on the market of the authorised product in the authorising Member State or on the Union market will cease to be valid.

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 for that product will cease to be valid.

Due to the current pandemic, initial market launch plans may need to be adapted in a way that could trigger the sunset clause mechanism. MAHs are reminded of the possibility to request an exemption in view of exceptional circumstances and on public health grounds.

For centrally authorised products such request has to be submitted under Article 14(6) of Regulation (EC) No 726/2004 to the European Commission. During the pandemic, the Commission may accept sunset clause requests that refer to the pandemic as a reason without the need for any further justification.

For nationally authorised products such requests have to be submitted to the competent authorities the Member State(s) concerned. It will be decided according to the national rules considering the pandemic situation.

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