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On 5 March 2021, the European Commission published guidance concerning handling of duplicate marketing authorisation applications of pharmaceutical products. The guidance provides applicants with further transparency and predictability in the process to obtain a duplicate marketing authorization.

The European Commission has published guidance to aid companies that wish to submit a request for an application for a duplicate marketing authorisation. The guidance provides detailed answers as to how article 82(1) of Regulation (EC) 726/2004 (“the regulation”) should be interpreted. Furthermore, the guidance explains the criteria the Commission uses when assessing a request for an application for a duplicate marketing authorisation. This article provides a brief outline of the most important issues in the guidance.

General information about marketing authorisation applications under the regulation
A marketing authorisation granted under the regulation allows the holder to market the medicinal product in the entire EU. The regulation limits the ability of an applicant/holder to obtain more than one marketing authorisation per medicinal product, cf. article 82(1).

However, the Commission shall authorise the same applicant to submit more than one application to the European Medicines Agency (EMA) for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.

Marketing authorisation applications under the scope of article 82(1)
Article 82(1) of the regulation concerns marketing authorization applications submitted by an applicant for a medicinal product for which they have already been granted a marketing authorization.

Though, a marketing authorization for a medicinal product that differs from a previously authorized product is not considered a duplicate and therefore does not need to be assessed under article 82(1). By contrast, a marketing authorization application for a medicinal product that has already been granted a marketing authorization does fall under article 82(1) if the applicant is the same as the one that holds the original marketing authorization.

When assessing whether an application falls under the scope of Article 82(1), the Commission will consider the composition in active substance(s) and the pharmaceutical form. The assessment must be done on a case-by-case basis looking at the facts of each application.

Finally, the Commission must consider the principle following from article 10(2)(b) of Directive 2001/83/EC. The article states that “the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy.”

Requirements to the authorization of duplicate marketing authorization applications
Applications for marketing authorizations, including duplicates, are submitted to the EMA.

The EMA controls that several conditions are met. First, that the duplicate application is submitted by the same applicant that submitted the original marketing authorization. Second, that the original marketing authorization is valid. Third, that there is a letter of consent from the marketing authorization holder in cases where the duplicate marketing authorization is submitted on the basis of an informed consent application. Finally, that an authorization by the Commission to submit a duplicate marketing authorization application has been granted.

Before granting an authorization as mentioned above, the Commission must be satisfied that the relevant conditions are met. It must verify that the applicant is the same applicant that submitted the original marketing authorization, and the public health reasons or co-marketing reasons are met.

Bech-Bruun’s comments 
Requests for duplicate marketing authorizations have increased steadily. According to the Commission, this development will only continue. It is our opinion that the guidance will ensure more transparency and predictability pointing forward for the parties who wish to submit a request for an application for a duplicate marketing authorization.

For more details on the guidance, click here.