national procedure, new application

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Marketing authorisation New Application National procedure Mututal recognition procedure (MRP) Decentralized Procedure (DCP) Centralized Procedure Information on the classification into sub-categories of the medicinal products authorised under centralised procedure Variations Renewals Product Information Cancellation Formal defect Homeopathic Medicinal Products Clinical trials Non-commercial clinical trials Scientific purpose certification Clinical Investigation Places Manufacturers' licences Wholesalers' licences Individual medicine import Authorisation of duty-free donations of medicines Laws and regulations Finance Forms	National procedure The assessment of the medicinal product’s documentation is done by the National Insitute of Pharmacy. The authorisation issued with the procedure is valid only in Hungary. Labels: national procedure, new application National Marketing Authorisation – New Application flow chart Labels: national procedure, new application Flowchart of the national procedure in case of new application. more > Validation criterions for new application Labels: national procedure, new application The requirements concerning the submission of application. more > Last updated: 2008.08.18 20:25 printer version
National Institute of Pharmacy \| H-1051 Budapest, Zrínyi u. 3. \| Mail: 1372 P.O. Box: 450. Tel: +36 1 88 69 -300 \| Fax: +36 1 88 69-460 \| Impressum \| Copyright Opening hours for docketing: Monday to Thursday: 8.30-12.00, Friday: 8.30-11.00