FarmavitaR+ is regulatory affairs community http://www.farmavitar.com 2010-03-12T22:49:19+01:00 http://www.farmavitar.com http://www.farmavitar.com/images/M_images/rss20.gif text/html 2009-08-11T13:21:37+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/843/51/ REGULATION FOR THE FOOD SUPPLEMENTS REGISTRATION IN THE REPUBLIC OF ALBANIA The Regulation for Food Supplements Registration is implemented for the food supplements which are introduced and marketed as alimentary products in the Republic of Albania. FarmavitaR+ brings you a short description of the food supplements registration procedure. The whole 8 pages article is available for download at Downloads (component/option,com_remository/Itemid,88/func,fileinfo/id,44/) section of Farmavitar.Net text/html 2009-08-11T13:01:29+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/842/51/ ON THE REGISTRATION OF THE HERBAL MEDICAL PRODUCTS IN THE REPUBLIC OF ALBANIA FarmavitaR+ brings you a short description of herbal medical products registration procedure in the Republic of Albania. The whole 4 pages article is available for download at Downloads (component/option,com_remository/Itemid,88/func,fileinfo/id,43/) section of Farmavitar.Net text/html 2009-08-06T13:15:12+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/841/51/ ON THE REGISTRATION OF THE DRUGS IN THE REPUBLIC OF ALBANIA FarmavitaR+ brings you a short description of drugs registration procedure in the Republic of Albania. The whole 12 pages article is available for download at Downloads (component/option,com_remository/Itemid,88/func,fileinfo/id,42/) section of Farmavitar.Net text/html 2009-07-22T09:53:27+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/840/51/ THE ROLE OF INTELLECTUAL PROPERTY RIGHTS IN TRADITIONAL KNOWLEDGE: AN OVERVIEW Intellectual properties (IP) are legal property rights over creations of the mind, both artistic and commercial, and the corresponding fields of law. Under intellectual property law, owners are granted certain exclusive rights to a variety of intangible assets, such as musical, literary, and artistic works; ideas, discoveries and inventions; and words, phrases, symbols, and designs. The whole 4 pages article is available for download at Downloads (component/option,com_remository/Itemid,88/func,fileinfo/id,41/) section of Faramavitar.Net text/html 2009-07-21T12:23:23+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/839/51/ Enforcement of new pricing and reimbursement ordinance in Croatia Croatian Institute for Health Insurance (HZZO) has informed all marketing authorization holders that 22nd August 2009 is deadline for adjustment of thier prices with Low on Medicines (Narodne Novine 71/07) and with new Ordinance about measures for determination of prices of medicines and ways for reporting about wholesale prices (Narodne Novine no. 60/08). text/html 2009-07-20T13:38:25+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/836/51/ Prasugrel: a flawed approval? On July 10, 2009, the FDA approved Effient (prasugrel) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndromes undergoing percutaneous coronary intervention. However, the approval has surprised many physicians as prasugrel has had a tortuous clinical development program, with important questions raised over its clinical benefits and the trial design. text/html 2009-07-09T12:47:31+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/829/51/ Some of the major wholesalers: text/html 2009-06-05T09:30:36+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/828/51/ Russia's Emerging OTC Market Holds Problems As Well As Promise Russia's rapidly growing over-the-counter market offers pharmaceutical companies a chance to expand their business, but its complex regulations and lengthy registration timelines may hinder entry. Russia is one of the biggest pearls, said Amra Pasovic, new and emerging markets regulatory affairs director with Johnson Johnson Group of Consumer Companies in Russia. text/html 2009-05-05T16:14:29+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/825/51/ The Difficulty in Readability Testing Since readability testing became a necessity for better patient understanding of leaflets, there has been a plethora of ways to test a leaflet. To the outsider, presenting a leaflet to a participant, asking a set of preset questions and recording the responses could appear to be enough to gauge the user friendliness of a Package Leaflet (PL). However, a simple yes/no dichotomic approach quickly yields an unforeseen variable which can aptly be demonstrated in the following hypothetical situation. text/html 2009-04-26T16:47:40+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/822/51/ TopPharm Consulting Poland Our company constitutes of people with high practical experience in EU regulatory affairs gained in Polish Authority and consulting companies. We are former Polish Authority experts who assessed dossier in national procedure, MRP, DCP, central procedure (EMEA) and were involved in preparation of Polish pharmaceutical regulations. If you are interested in marketing authorization of medicinal products, medical devices, food supplements and cosmetics in Poland and in EU please visit our website: office@toppharm.pl (mailto:office@toppharm.pl) text/html 2009-04-21T14:26:00+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/817/51/ Notice on change of access to information on centrally authorised medicinal products The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC) of centrally authorised medicinal products, with a table in Excel format including the following data: name of centrally authorised medicinal products, medicinal product registration number in the Community Register of centrally authorised medicinal products and the marketing authorisation holder (MAH). text/html 2009-04-21T14:23:17+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/816/51/ Important notice to the attention of Marketing Authorisation Holders The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 16th 17th February 2009 (http://www.hma.eu/186.html (http://www.hma.eu/186.html)) text/html 2009-04-21T14:16:26+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/815/51/ Romania - Important notice to the attention of Marketing Authorisation Holders The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 19th and 20th January 2009 (http://www.hma.eu/186.html (http://www.hma.eu/186.html)) Question and Answer – Article 5 of Regulation (EC) No 1234/2008 The CMD(h) has agreed a Q A (http://www.hma.eu/120.html (http://www.hma.eu/120.html)) to clarify that Article 5 of Regulation (EC) No 1234/2008, applicable as of 1st January 2009, can only be used to request the provision of a recommendation on the classification of a variation according to Commission Regulation (EC) No 1234/2008 and not according to the Commission Regulation (EC) No 1084/2003, in force until 31st December 2009. text/html 2009-04-21T13:03:44+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/814/51/ Romania - Important notice to the attention of Marketing Authorisation Holders - Name of the medicinal product; - International Non-Proprietary Name (INN) of the active substance contained in the respective medicinal product; - Approved therapeutic indication(s); - Approved presentation forms; - Registration number in the Register of medicinal products for human use authorised by the Community under the centralised procedure; - Authorisation date; - Procedure closure date; - Type of procedure; - Procedure number as given by the European Medicines Agency (EMEA); - Number of the EC decision; - Historic progress of post-authorisation changes, with approval decisions: variations, renewals, transfers; - Annexes to decisions: - Annex I - SPC - Annex II - Marketing Authorisation Holder and conditions for authorisation - Annex III – Leaflet and Labelling. text/html 2009-02-11T16:32:28+01:00 http://www.farmavitar.com http://www.farmavitar.com/content/view/813/51/ Bulgaria Will be a reference Member State BDA triggers a timetable definition in order to prepare slots for assessment of the marketing authorization applications in MRP and DCP procedures for which Bulgaria is to be a reference Member State under Art. 76 (1) and (3) of LMPHM.