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European Medicines Agency (EMA)
Article 57

Article 57

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1.
The Agency shall provide the Member States and the institutions of the Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human use or veterinary medicinal products which is referred to it in accordance with the Union legislation relating to medicinal products for human use or veterinary medicinal products.

To that end, the Agency, acting particularly through its committees, shall carry out the following tasks:

(a)

coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use and of veterinary medicinal products which are subject to Union marketing authorisation procedures;

(b)

transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets for the medicinal products for human use;

(c)

coordinating the monitoring of medicinal products for human use and of veterinary medicinal products which have been authorised in the Union and providing advice on the measures necessary to ensure the safe and effective use of those products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;

(d)

ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products for human use and to veterinary medicinal products authorised in the Union by means of databases that are permanently accessible to all Member States;

(e)

assisting Member States with the rapid communication of information on pharmacovigilance concerns relating to medicinal products for human use to healthcare professionals and coordinating the safety announcements of the national competent authorities;

(f)

distributing appropriate information on pharmacovigilance concerns relating to medicinal products for human use to the general public, in particular by setting up and maintaining a European medicines web-portal;

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(i)

coordinating, as regards medicinal products for human use and veterinary medicinal products, the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and, as regards medicinal products for human use, the verification of compliance with pharmacovigilance obligations;

(j)

upon request, providing technical and scientific support in order to improve cooperation between the Union, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products for human use and of veterinary medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation;

(k)

recording the status of marketing authorisations for medicinal products for human use and for veterinary medicinal products granted in accordance with Union marketing authorisation procedures;

(l)

creating a database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

(m)

assisting the Union and its Member States in the provision of information to health-care professionals and the general public about medicinal products for human use and about veterinary medicinal products evaluated by the Agency;

(n)

advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products for human use and of veterinary medicinal products;

(o)

checking that the conditions laid down in Union legislation on medicinal products for human use and on veterinary medicinal products and in the marketing authorisations are met in the case of parallel distribution of medicinal products for human use and on veterinary medicinal products authorised in accordance with this Regulation or, as applicable, Regulation (EU) 2019/6;

(p)

drawing up, at the Commission’s request, any other scientific opinion concerning the evaluation of medicinal products for human use and of veterinary medicinal products or the starting materials used in the manufacture of medicinal products for human use and of veterinary medicinal products;

(q)

with a view to the protection of public health, compiling scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products for human use and other veterinary medicinal products available to prevent or treat the effects of such agents;

(r)

coordinating the supervision of the quality of medicinal products for human use and of veterinary medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose;

(s)

forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures for medicinal products for human use and veterinary medicinal products;

(t)

taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council (3);

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(u)

contributing to the joint reporting with the European Food Safety Authority and European Centre for Disease Prevention and Control on the sales and use of antimicrobials in human and veterinary medicine as well as on the situation as regards antimicrobial resistance in the Union based on contributions received by Member States, taking into account the reporting requirements and periodicity in Article 57 of Regulation (EU) 2019/6. Such joint reporting shall be carried out at least every three years.

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2.
The database provided for in point (l) of paragraph 1 of this Article shall include the summaries of product characteristics, the package leaflet and the information shown on the labelling. That database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.
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For the purposes of the database, the Agency shall set up and maintain a list of all medicinal products for human use authorised in the Union. To this effect the following measures shall be taken:

(a)

the Agency shall, by 2 July 2011 at the latest, make public a format for the electronic submission of information on medicinal products for human use;

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(b)

marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in point (a);

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(c)

from the date set out in point (b), marketing authorisation holders shall inform the Agency of any new or varied marketing authorisations granted in the Union, using the format referred to in point (a).

▼B

Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.