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Provision of information necessary for submitting data on medicinal products for human use required by the pharmacovigilance rules only in English
Caso 889/2012/VL - Aperto(a) il Martedì | 29 maggio 2012 - Decisione del Giovedì | 26 settembre 2013 - Istituzione coinvolta Agenzia europea per i medicinali ( Risoluzione da parte dell’istituzione )
Allegation(s)
1) EMA wrongly failed to make available in languages other than English, information necessary for the submission of data on medicinal products, and information on the assistance it offers to small and medium-sized enterprises, in breach of Regulation 1/58 and of the principle of non-discrimination, since it discriminates against undertakings whose working language is not English.
2) EMA wrongly failed to reply to the substance of the complainant's e-mail of 4 April 2012.
3) In its interim reply to the complainant, EMA wrongly failed to use German, the Treaty language in which the complainant had written to it.
Claim(s)
1) EMA should make the information which undertakings need in order to comply with their pharmacovigilance obligations, and the guidance it gives to undertakings, in particular small and medium-sized enterprises, available in the official languages of the EU, notably where the information and guidance are aimed at undertakings that are only active on national markets.
2) EMA should reply to the substance of the complainant's e-mail of 4 April 2012.