| FORM PAYMENT OF AUTHORISATION FEE FOR MEDICINAL PRODUCTS SUBMITTED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION PROCEDURE OR DECENTRALISED PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE download document …  download document …  |
| Payment form fee for scientific opinion/change of scientific opinion on ancillary active substance(s) incorporated in medical devicex download document … download document … |
| APPLICATION FORM – Supplementary consultation for scientific opinion on ancillary active substance(s) incorporared in medical device download document … download document … |
| APPLICATION FORM – Initial consultation for scientific opinion on ancillary active substance(s) incorporared in medical device download document … download document … |
| APPLICATION FORM concerning assessment of medical technologies download document … download document … |
| FORM PAYMENT OF FEE for assessment of medical technologies download document … download document … |
| TARIFFS for assessment of documentation in view of marketing authorisation/marketing authorisation renewal/marketing authorisation variation of medicinal products for human use and development of marketing authorisation related activities in accordance with Law no. 95/2006 as amended, Order of the Minister of Health no. 716/2009 published in the Official Gazette of Romania, Part I, no. 422 of 19 June 2009 and Order No.868 of 07.09.2012 published in the Official Gazette of Romania, Part I, no. 667 of 24 September 2012 download fees … |
| APPLICATION FORM APPROVAL OF EDUCATIONAL MATERIAL download document … download document … |
| FORM PAYMENT OF FEE FOR ASSESSMENT OF EDUCATIONAL MATERIAL download document … download document … |
| Letter of intent for the submission of an application for marketing authorisation transfer/notification download document … download document … |
| Letter of intent for the submission of a variation download document … download document … |
| PAYMENT FORM TARIFF FOR VARIATIONS OF A MARKETING AUTORISATION, TRANSFER OF A MARKETING AUTORISATION AND OTHER CHANGES TO MARKETING AUTORISATION FOR MEDICINAL PRODUCTS AUTHORISED THROUGH MUTUAL RECOGNITION PROCEDURE OR DECENTRALISED PROCEDURE download document … download document … |
| TAX AND TARIFF PAYMENT FORM MARKETING AUTHORISATION / MARKETING AUTHORISATION RENEWAL download document … download document … |
| TAX AND TARIFF PAYMENT FORM AUTHORISATION FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION PROCEDURE OR DECENTRALISED PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE download document … download document … |
| TAX AND TARIFF PAYMENT FORM MARKETING AUTHORISATION RENEWAL FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE download document … download document … |
| TAX AND TARIFF PAYMENT FORM AUTHORISATION FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION PROCEDURE OR DECENTRALISED PROCEDURE WITH ROMANIA AS REFERENCE MEMBER STATE download document … download document … |
| PAYMENT FORM FEES FOR TYPE IA VARIATIONS, TYPE IA VARIATIONS DESCRIBING THE GROUP, TYPE IA VARIATIONS INCLUDED INTO THE GROUP, TYPE IB VARIATIONS, TYPE IB VARIATIONS DESCRIBING THE GROUP, TYPE IB VARIATIONS INCLUDED INTO THE GROUP, TYPE II VARIATIONS, TYPE II VARIATIONS DESCRIBING THE GROUP, TYPE II VARIATIONS INCLUDED INTO THE GROUP, TRANSFER OF MARKETING AUTHORISATION AND OTHER CHANGES TO MARKETING AUTHORISATION download document … download document … |
| PAYMENT FORM CLINICAL TRIAL TARIFF download document … download document … |
| PAYMENT FORM TARIFF ON ASSESSMENT OF ADVERTISING OF MEDICINAL PRODUCTS FOR HUMAN USE download document … download document … |
| PAYMENT FORM TARIFF FOR GRANT OF WHO – FORMAT MEDICINAL PRODUCT CERTIFICATE download document … download document … |
| Application for transfer of a marketing authorisation download document … download document … |
| Application for marketing authorisation of homeopathic medicinal products for human use download document … download document … |
| Application for marketing authorisation of medicinal products for human use download document … download document … |
| Application for renewal of a marketing authorisation for medicinal products for human use download document … download document … |
National Agency for Medicines and Medical Devices of Romania
