{"id":8251,"date":"2018-06-21T17:06:59","date_gmt":"2018-06-21T14:06:59","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=8251"},"modified":"2024-02-27T16:42:36","modified_gmt":"2024-02-27T13:42:36","slug":"formulare-si-tarife","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/formulare-si-tarife\/","title":{"rendered":"Forms and tariffs \u2013 Medicines for human use"},"content":{"rendered":"\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\nPAYMENT 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 \u2013 Supplementary consultation for scientific opinion on ancillary active substance(s) incorporared in medical device
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APPLICATION FORM \u2013 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 the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medicinal products for human use – marketing authorisation and related activities
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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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\nTAX AND TARIFF PAYMENT FORM for MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH NATIONAL PROCEDURE
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\nTAX AND TARIFF PAYMENT FORM for MARKETING AUTHORISATION RENEWAL FOR MEDICINAL PRODUCTS PROPOSED FOR AUTHORISATION THROUGH NATIONAL PROCEDURE
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\nPAYMENT 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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\nPAYMENT FORM TARIFF FOR IMPORT PARALLEL AUTHORISATION
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\nPAYMENT FORM TARIFF FOR VARIATIONS OF AN IMPORT PARALLEL AUTHORISATION
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\nPAYMENT 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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\nPAYMENT 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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\nPAYMENT 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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\nPAYMENT 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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\nPAYMENT 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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\nPAYMENT FORM AUTHORISATION OF CLINICAL TRIALS\/APPROVAL OF SUBSTANTIAL AMENDMENTS
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\nPAYMENT FORM TARIFF ON ASSESSMENT OF ADVERTISING OF MEDICINAL PRODUCTS FOR HUMAN USE
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\nPAYMENT FORM FEE FOR GRANT OF WHO – FORMAT MEDICINAL PRODUCT CERTIFICATE
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\nApplication for transfer of a marketing authorisation
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\nApplication for marketing authorisation of homeopathic medicinal products for human use
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\nApplication for marketing authorisation of medicinal products for human use
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\nApplication for renewal of a marketing authorisation for medicinal products for human use
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\nDefective product report
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PAYMENT FORM FEE FOR SETUP AND UPDATE OF THE INDEX OF MEDICINAL PRODUCTS FOR HUMAN USE download document … download […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":467,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-8251","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8251","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=8251"}],"version-history":[{"count":4,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8251\/revisions"}],"predecessor-version":[{"id":10170,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/8251\/revisions\/10170"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/467"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=8251"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}