FILL-IN FORMS AND FEES

 

FORM PAYMENT OF AUTHORISATION FEE FOR MEDICINAL PRODUCTS SUBMITTED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION PROCEDURE OR DECENTRALISED PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE
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Payment form fee for scientific opinion/change of scientific opinion on ancillary active substance(s) incorporated in medical devicex
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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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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
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TAX AND TARIFF PAYMENT FORM MARKETING AUTHORISATION / MARKETING AUTHORISATION RENEWAL
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PAYMENT OF FEE FOR DRAFT AND UPDATE OF THE INDEX OF MEDICINAL PRODUCTS FOR HUMAN USE
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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
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TAX AND TARIFF PAYMENT FORM MARKETING AUTHORISATION RENEWAL FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH MUTUAL RECOGNITION PROCEDURE WITH ROMANIA AS CONCERNED MEMBER STATE
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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
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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 CLINICAL TRIAL TARIFF
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PAYMENT FORM TARIFF ON ASSESSMENT OF ADVERTISING OF MEDICINAL PRODUCTS FOR HUMAN USE
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PAYMENT FORM TARIFF 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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