Products For Use With Covid-19The current document answers questions related to marketing authorisation procedures, manufacturing and importation of finished products and APIs, quality variations and product information and labelling. Marketing Authorisation Holders are encouraged to address the EMA for centrally authorised products or the relevant national competent authority with queries related to specific products not addressed in the current document. For queries related to medicinal products intended for use in patients with Covid-19, “CONCERNS COVID-19” should be included in the subject section to ensure prompt assessment of any such requests. The options for marketing medicinal products for use in Covid-19 patients are outlined. These include:
- the use of zero-day mutual recognition procedure/repeat use procedure,
- authorisation in accordance with Article 126a of Directive 2001/83 EC
- or, authorisation of the distribution of an unauthorised medicine in accordance with Article 5(2) of Directive 2001/83 EC.