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Paediatric Use Marketing Authorisations (PUMAs)?


The paediatric-use marketing authorisation (PUMA) is a new type of marketing authorisation. It may be requested for a medicine which is already authorised, but no longer covered by intellectual property rights (patent, supplementary protection certificate), and which will be exclusively developed for use in children.

This type of marketing authorisation will cover the indication and appropriate formulation for the paediatric population. The development of this medicine in children will follow a paediatric investigation plan (PIP). This PIP, which must discuss all paediatric subsets, will have to be agreed by the Paediatric Committee.

A paediatric-use marketing authorisation will benefit from 10 years of market protection as a reward for the development in children. This is made up of 8 years data exclusivity plus an additional two years marketing exclusivity.

Update: Midazolam (Buccolam), the first PUMA, was authorised on 5th September 2011.

What is a Paediatric Use Marketing Authorisation (PUMA)?

According to Article 30 of Regulation (EC) No 1901/2006 (“Paediatric Regulation”), the paediatric use marketing authorisation (PUMA) is a dedicated marketing authorisation for medicinal products indicated exclusively for use in the paediatric population, or subsets thereof, with, if necessary, an age-appropriate formulation. It has been designed to promote paediatric development of already authorised products which are no longer covered by a supplementary protection certificate (SPC) or a patent qualifying for a SPC.

The key points of a PUMA are summarized below:

  • The medicinal product is intended exclusively for use in the paediatric population.
  • The centralised procedure is available for any PUMA application (“automatic access”) (see Q.2).
  • The application dossier must include the documents necessary to establish quality, safety and efficacy in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed paediatric investigation plan (PIP) (see Q.3 and Q4).
  • Applications for a PUMA can cross-refer to the relevant data in the dossier of an authorised medicinal product, without prejudice to data protection rules that may be applicable (see Q.3).
  • PUMA benefits from dedicated incentives, notably regarding the regulatory data protection and the name of the product (see Q.5).

Which authorisation route is used for PUMA applications?

The existing marketing authorisation procedures, i.e. the centralised, Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), or national procedure, apply.

A PUMA application remaining outside the mandatory scope of Article 3(2)(a) of Regulation (EC) No 726/2004 has an ‘automatic access’ to the centralised procedure (Article 31 of the Paediatric Regulation) if the applicant chooses this route of registration.

Before a PUMA application is submitted for the centralised procedure, an eligibility confirmation must be requested by the applicant by submitting a Pre-submission request form (Eligibility)

What is the content of a PUMA application?

The same range of supporting documentation should be provided as for other marketing authorisation applications through a combination of new data and/or existing data. Depending on the legal basis of the application, submission of literature and/or cross-reference to the dossier of another medicinal product may be used. In particular, cross-reference to the data contained in the dossier of an authorised medicinal product is possible if the relevant data protection has expired.

A PUMA application has to contain the results of all studies performed and details of all information collected in compliance with an agreed Paediatric Investigation Plan (PIP). The corresponding EMA decision as well as the PDCO opinion on compliance or the applicant’s compliance report must be provided.

As per Article 34 of the Paediatric Regulation, applicants are required to detail in a risk-management plan submitted with their PUMA application the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product.

Is a paediatric investigation plan (PIP) needed to submit a PUMA application?

Yes. PUMA applications are submitted on a voluntary basis, however, according to Article 30(2) of the Paediatric Regulation, a PUMA application has to contain the results of studies performed and information collected in compliance with an agreed PIP. The corresponding EMA decision as well as the PDCO opinion on compliance or the applicant’s compliance report must be provided.

What are the incentives for a PUMA?

The incentives are:

  • PUMA applications have an ‘automatic access’ to the centralised procedure (Article 31 of the Paediatric Regulation).
  • A PUMA benefits from the 8+2 year period of data and market protection (Article 38 of the Paediatric Regulation).
  • A medicinal product in respect of which a PUMA has been granted may retain the name of another medicinal product containing the same active substance and in respect of which the same holder has been granted an authorisation for use in adults (Article 30(4) of the Paediatric Regulation).
  • PUMA applications submitted under the centralised procedure benefit from a partial exemption from the payment of the fees laid down in the Regulation (EC) No 297/95. This partial exemption applies to the submission of the PUMA application and some of the post-authorisation activities for 1 year as of the date of granting a PUMA. Please refer to the Regulation (EC) No 297/95 and the Explanatory note on fees payable to the European Medicines Agency.

Is it possible to apply for a PUMA if a product, authorised for use in adults, is still covered by intellectual property rights?

No. If an authorised medicinal product is still protected by a supplementary protection certificate (SPC) or by a patent which qualifies for the granting of a supplementary protection certificate under Regulation (EC) No 469/2009 (previously Regulation (EEC) No 1768/92), a PUMA application is not available.

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