WebINFARMED - National Authority of Medicines and Health Products, I.P. is a Government agency accountable to the Health Ministry. It's mission is to monitor, … Web24 okt. 2024 · O INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P., abreviadamente designado por INFARMED, I. P., é um instituto público integrado na administração indirecta do Estado,...
BfArM - Costs
Webmedicinal product, payment of fees and the different modalities of dossier submission, electronic or paper submission, both and/or in parallel, should be clarifiedand taken into consideration in order to assure a smooth dossier submission. WebRegistration Requirement. 145/2009 published on 17 June 2009 and transposed into Portuguese law Directive No. 2007/47/CE of European Parliament and Council, All Medical Devices must have CE marking and must be registered online with the national regulatory authority, INFARMED. If the manufacturer is headquartered outside the European Union, … radius of 29
Medical devices - INFARMED, I.P.
WebThe payment of fees should be made via RNEC portal. Fee Exemption In accordance with the article 3 of ordinance no. 63/2015, of 5 March, a fee exemption may be granted by … Web19 sep. 2013 · 8.7. Fees applicable to variation applications in categories A.1 and A.7..... 16 8.8. Fees applicable to variation applications in categories A.1, A.4 and A.5... 16 Annex I … Web21 dec. 2024 · There are no recommended submission dates for 61(3) notification. Hence, the MAH can submit a 61(3) notification at any time. The Agency strongly recommends that whenever possible the marketing authorisation holder (MAH) includes these minor changes to the labelling and/or PL as part of another on-going or upcoming regulatory procedure … radius of 3959 miles