PAYMENT FORM FEE FOR SETUP AND UPDATE OF THE INDEX OF MEDICINAL PRODUCTS FOR HUMAN USE
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Payment form fee for scientific opinion/change of scientific opinion on ancillary active substance(s) incorporated in medical device
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APPLICATION FORM – Supplementary consultation for scientific opinion on ancillary active substance(s) incorporared in medical device
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APPLICATION FORM – Initial consultation for scientific opinion on ancillary active substance(s) incorporared in medical device
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APPLICATION FORM concerning assessment of medical technologies
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FORM PAYMENT OF FEE for assessment of medical technologies
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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
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APPLICATION FORM APPROVAL OF EDUCATIONAL MATERIAL
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FORM PAYMENT OF FEE FOR ASSESSMENT OF EDUCATIONAL MATERIAL
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Letter of intent for the submission of an application for marketing authorisation transfer/notification
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Letter of intent for the submission of a variation
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TAX AND TARIFF PAYMENT FORM for MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH NATIONAL PROCEDURE
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TAX AND TARIFF PAYMENT FORM for MARKETING AUTHORISATION RENEWAL FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH NATIONAL PROCEDURE
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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
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PAYMENT FORM TARIFF FOR IMPORT PARALLEL AUTHORISATION
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PAYMENT FORM TARIFF FOR VARIATIONS OF AN IMPORT PARALLEL AUTHORISATION
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PAYMENT FORM FOR THE TARIFF FOR MARKETING AUTHORISATION ACCORDING TO ARTICLE 893 OF LAW NO. 95/2006 AND THE TARIFF FOR THE ASSESSMENT OF DOCUMENTATION IN VIEW OF MARKETING AUTHORISATION RENEWAL ACCORDING TO MINISTER OF HEALTH ORDER NO. 888/2014 FOR MEDICINAL PRODUCTS AUTHORISED THROUGH MUTUAL RECOGNITION OR DECENTRALISED PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE
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PAYMENT FORM FOR THE TARIFF FOR MARKETING AUTHORISATION ACCORDING TO ARTICLE 893 OF LAW NO. 95/2006 AND THE TARIFF FOR THE ASSESSMENT OF DOCUMENTATION IN VIEW OF MARKETING AUTHORISATION ACCORDING TO MINISTER OF HEALTH ORDER NO. 888/2014 FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION OR DECENTRALISED PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE
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PAYMENT FORM FOR THE TARIFF FOR MARKETING AUTHORISATION ACCORDING TO ARTICLE 893 OF LAW NO. 95/2006 AND THE TARIFF FOR THE ASSESSMENT OF DOCUMENTATION IN VIEW OF MARKETING AUTHORISATION ACCORDING TO MINISTER OF HEALTH ORDER NO. 888/2014 FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION OR DECENTRALISED PROCEDURE WITH ROMANIA AS REFERENCE MEMBER STATE
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PAYMENT FORM FOR THE TARIFF FOR MARKETING AUTHORISATION ACCORDING TO ARTICLE 893 OF LAW NO. 95/2006 AND THE TARIFF FOR THE ASSESSMENT OF DOCUMENTATION IN VIEW OF MARKETING AUTHORISATION RENEWAL ACCORDING TO MINISTER OF HEALTH ORDER NO. 888/2014 FOR MEDICINAL PRODUCTS AUTHORISED THROUGH MUTUAL RECOGNITION OR DECENTRALISED PROCEDURE WITH ROMANIA AS REFERENCE MEMBER STATE
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PAYMENT FORM TARIFF FOR TYPE IA, TYPE IB, TYPE II VARIATIONS OF A MARKETING AUTHORISATION, TRANSFER OF A MARKETING AUTHORISATION AND OTHER CHANGES TO MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS AUTHORISED THROUGH MUTUAL RECOGNITION PROCEDURE OR DECENTRALISED PROCEDURE
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PAYMENT FORM AUTHORISATION OF CLINICAL TRIALS/APPROVAL OF SUBSTANTIAL AMENDMENTS
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PAYMENT FORM TARIFF ON ASSESSMENT OF ADVERTISING OF MEDICINAL PRODUCTS FOR HUMAN USE
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PAYMENT FORM FEE FOR GRANT OF WHO – FORMAT MEDICINAL PRODUCT CERTIFICATE
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Application for transfer of a marketing authorisation
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Application for marketing authorisation of homeopathic medicinal products for human use
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Application for marketing authorisation of medicinal products for human use
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Application for renewal of a marketing authorisation for medicinal products for human use
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Defective product report
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