MedTechbloggen

Vårt svenska Läkemedelsverk har överskridit sina befogenheter och fått sig en näsknäpp av Europeiska kommissionen. Läkemedelsverket ställer krav på registrering av alla kosmetiska och hygieniska produkter som importeras till Sverige, LVFS 2004:12. Det får man inte göra. Kosmetiska och hygieniska produkter från EU/EES-medlemsstater får nu helt fritt, från andra regulatoriska krav än de EU/EES-gemensamma, importeras. Det innebär att Läkemedelsverket upphör att i produktregistret registrera nya produkter och verksamheter avseende produkter som förs in från annan EU/EES-medlemsstat.
“Läkemedelsverket kommer vidare inom kort att se över de ifrågasatta registreringskraven i LVFS 2004:12. Kraven på anmälan vid införsel av kosmetiska och hygieniska produkter från EU/EES-medlemsstater kommer därmed att tas bort. Föreskriftsändringen beräknas träda i kraft senast den 31 december 2010.”
Alla förenklingar av byråkratiskt krångel mottas med glädje av de flesta.

Kosmetika från/till Kina?

SFDA defines application requirements for fragrance materials in cosmetic formulations
In order to enhance the management of the application of fragrance materials in cosmetic formulations, The State Food and Drug Administration (SFDA) recently issued a notice on relevant issues concerning the application of fragrance materials in cosmetic formulations.

Kinas “läkemedelsverk” höjer aktiviteten inom kosmetikaområdet:

“The State Food and Drug Administration (SFDA) recently issued Measures for Cosmetic Administrative Licensing Testing and Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions.

Measures for Cosmetic Administrative Licensing Testing specifies the relevant responsibilities of administrative licensing testing. The Measures, comprising eight chapters and 31 articles, came into effect as of February 11, 2010. The Measures shall prevail where previous documents are inconsistent with it. The Requirements for Cosmetic Administrative Licensing Testing issued at the same time consists of six chapters and 39 articles.

Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions specifies the qualification of cosmetic administrative licensing testing institutions. The measures, comprising five chapters and 23 articles, came into effect as of February 11, 2010. The Measures shall prevail where previous documents are inconsistent with it. The Requirements for Qualification of Cosmetic Administrative Licensing Testing Institutions issued at the same time consists of five chapters and 31 articles.”

Kosmetik i Kina. Nya guidelines utgivna av SFDA.

“In order to meet the needs of administrative licensing for cosmetics, intensify supervision on the naming of cosmetics, ensure scientific and standardized naming of cosmetics, and protect the rights and interests of consumers, the State Food and Drug Administration (SFDA) formulated and issued Requirements on Naming of Cosmetics and Guide to the Naming of Cosmetics in accordance with Regulations Concerning the Hygiene Supervision Over Cosmetics and the rules for the implementation of the Regulations.

To better implement Requirements on Naming of Cosmetics and Guide to the Naming of Cosmetics, SFDA released Notice on Issues Concerning Implementation of Requirements on Naming of Cosmetics and Guide to the Naming of Cosmetics.”

EPHA är glada för portföljbyte. Pressrelease 27/11 -09

José Manuel Barroso, President of the European Commission, has announced today the portfolio responsibilities for the next Commission. The new Health and Consumer Policy portfolio will now include responsibility for pharmaceutical products and medical devices. These changes will be reflected at the level of the directorate generals, with the Pharmaceutical Products and Cosmetics and Medical Devices Units F.2 and F.3, and consequenlty the European Medicines Agency, moved from DG Enterprise and Industry (ENTR) to DG Health and Consumers (SANCO).

“We are certain that this governance change puts public interests and the health of Europeans at the centre of vital decisions affecting our health. With the responsibility for pharmaceutical and medical devices policies and for the European Medicines Agency too, the Health and Consumer Policy Commissioner is now better equiped to lead a consistent and coherent approach to public health policy and more specifically to ensure protection of patients and safety of medicines throughout the European Union.”, said Monika Kosinska, Secretary General of the European Public Health Alliance. Moreover, “This bold decision by President Barroso demonstrated the power of political leadership and enables the European Commission to fulfill its Treaty responsibility as the guardian of public health.”, she added.