Application for authorisation of medicinal product compassionate use – Physician
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Application for authorisation of medicinal product compassionate use – Manufacturing company
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Healthcare facility Agreement – Last resort treatment
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Payment Form – Fee for set up and update of the Medicinal Product Index
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Application Form – Supplementary consultation for scientific opinion on quality and safety of ancillary active substance on the quality and safety of the ancillary active substance(s) incorporated as an integral part in the medical device
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Application Form – Initial consultation for scientific opinion for scientific opinion on quality and safety of ancillary active substance on the quality and safety of the ancillary active substance(s) incorporated as an integral part in the medical device
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Application Form – Assessment of Health Technologies
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Payment Form – Fee for assessment of health technologies
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Payment Form – Fee for scientific opinion/change of scientific opinion on ancillary active substance(s) incorporated as an integral part in the medical device
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Application Form – Variation to MA terms
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Fees for assessment of documentation for marketing authorisation/ marketing authorisation renewal/variation to marketing authorisation terms of medicinal products for human use and conduct of marketing authorisation–related activities pursuant to Law 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 19.06.2009 and Order of the Minister of Health no. 868/2012, published in the Official Gazette of Romania, Part I, no.667 of 24.09.2012
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Application Form – Approval of advertising for medicinal products for human use
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Application Form – Approval of educational material
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Application Form – Marketing authorisation of medicinal products for human use
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Application Form – Renewal of marketing authorisation of medicinal products for human use
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Application Form – Marketing authorisation of homeopathic medicinal products for human use
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Application Form – Variation to marketing authorisation terms
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Application Form – Authorisation for supply of medicinal products for special needs pursuant to art. 699 (1) of Law no. 95/2006 on healthcare reform
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Application Form – Authorisation for supply of medicinal products for special needs pursuant to art. 699 (2) of Law no. 95/2006 on healthcare reform
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Payment Form – Assessment of educational material
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Payment Form – Assessment of advertising for medicinal products for human use
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Application Form – Accreditation for consultation with target groups for medicinal product leaflet
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Payment Form – Parallel import authorisation fee
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Payment Form – Fee for variation to parallel import authorisation terms
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Payment Form – Fees for marketing authorisation/ marketing authorisation renewal
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Payment Form – Fees for renewal of marketing authorisation for medicinal products proposed through Mutual Recognition and Decentralised procedures with Romania as Concerned Member State
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Payment Form – Fees for marketing authorisation for medicinal products proposed through Mutual Recognition and Decentralised procedures with Romania as Concerned Member State
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Payment Form – Fees for marketing authorisation for medicinal products proposed through Mutual Recognition and Decentralised procedures with Romania as Reference Member State
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Payment Form – Fees for Type IA variations, Type IA defining the group, Type IA included into the group, Type IB variations, Type IB defining the group, Type IB included into the group, Type II variations, Type II defining the group, Type II included into the group, marketing authorisation transfer and other changes to marketing authorisation
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Payment Form – Fee for authorisation of clinical trial/approval of amendments
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Payment form – Fess for Type IA, Type IB, type II, marketing authorisation transfer and other changes to marketing authorisation for medicinal products authorised through mutual recognition and decentralised procedures
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Payment Form – Fee for grant of medicinal product WHO format certificate
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Export declaration
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Wholesale Distribution Site Master File
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Marketing Authorisation Holder Pharmacovigilance System Master File
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Preclinical Testing Site Master File
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Manufacturing/Import/Testing Site Master File
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Versiunea in limba engleza:
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Application Form – Accreditation certificate for consultation with target groups for medicinal product leaflet
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Application Form – Planning of inspection for wholesale distribution site authorisation/GMP certification
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Application Form – Authorisation of wholesale distribution of medicinal products for human use
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Application Form – Issue of duplicate wholesale distribution authorisation/GMP certificate in case of loss
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Form for importer submission of import related information
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Application Form – Approval of export declaration
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Application Form – Grant of certificate for manufacturing/import authorisation holder Qualified Person
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Application Form – Issue of duplicate certificate for manufacturing/import authorisation holder Qualified Person in case of loss
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Application Form – Planning of inspection for manufacturing/import/testing authorisation/ GMP certification
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Application Form – Grant of manufacturing authorisation
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Application Form – Grant of manufacturing authorisation – Investigational medicinal products for human use
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Application Form – Issue of duplicate certificate for manufacturing /GMP certificate in case of loss
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Template for Undertaking for individual imports
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Template for Marketing Authorisation Holder notification of the National Agency for Medicines and Medical Devices on intended marketing in Romania of a batch of biological product for human use
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Application Form – Registration of brokers of medicinal products for human use
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Payment Form – Fee for entry into the Registry of brokers of medicinal products for human use
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Application Form – Conduct of inspection for GMP certification
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