E-mail

info@baupharma.com

Update multi-language labelling in EU

Baupharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EU, CIS, MENA, Registration, Renewal, variation, license, local QPPV, EU QPPV, Safety Officer, in licenses, out license, risk management plan, PSUR, Price and reimbursement, cpp, certificate pharmaceutical product, distributor, local company representatives, sales forces, environmental risk assessment, psmf, nonclinical overview, clinical overview, DSUR, SOP, CAPA, CA/PA, PIL, PL, SMPC, Labelling, literature articles, phv, marketing, marketed, MAH, PSMF, literature research, local literature research, global literature research, safety, ICSR, XEVMPD, IDMP, CP, DCP, NP, centralize procedure, decentralize procedure, national procedure, GCC, submission, regulatory support, gap analysis, ectd, e-ctd, publishing, module 1, module 2, module 3, module 4, module 5preparation, cover letter, application form, electronic application form, artwork, braille, mockup, mock up, mock-up, consultation with target patient groups, readability testing, nonclinical summary, clinical summary, NEES, ctd, pharmaceuticals, pharma, we build pharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 14 Feb

Update multi-language labelling in EU

Update multi-language labelling EU

Looks like January was a productive month for CMDh. On their last meeting they have agreed to publish a set of links with special guidance on update multi-language labelling EU developed by some Member States. The update of multi-language labelling in EU will be available under “Product Information” on their website section.

As an illustration, if you have products in Finland, Sweden or Belgium, this is a great piece of news. Regarding those countries, multi language packaging is mandatory. Especially, when you are preparing your SmPC, PIL and Labels. You have to focus not only in content and current QRD but also in the local guidelines and recommendations. With this in mind, it is especially tricky on those countries where labelling is in different languages as you have to check different sources. Finally, most of the information of EU regarding this topic will be centralized.

Baupharma is a service provider for pharmaceutical companies, covering Regulatory AffairsPharmacovigilance and Business Development. Our regions of expertise are EUCIS and MENA.

If you want further information, feel free to contact us at info@baupharma.com