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Registration Pharmaceutical Industry

Hogan Lovells

Médicaments hybrides et inscription au répertoire des groupes génériques

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Le Conseil d’Etat confirme que seule la décision d’autorisation de mise sur le marché peut définir un médicament en tant que générique. Par deux décisions récentes du 7 juillet 2021 (Johnson & Johnson, req. n° 437803 et...more

Hogan Lovells

Hybrid products and registration in the generics register ("répertoire des groupes génériques")

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The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic. In two recent decisions of 7 July 2021 (Johnson & Johnson, req. no....more

Hogan Lovells

Medical devices in the EU - Update on EUDAMED database: The first module is here!

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The first module of the European database on medical devices, EUDAMED, also referred to as the Actor registration module, will be made available to EU Member States and economic operators on 1 December 2020....more

McDermott Will & Emery

HRSA Announces New Registration and Recertification Requirements for 340B Program

McDermott Will & Emery on

The Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) recently issued a new Program Update that includes new covered entity registration and recertification requirements, as well as...more

Hogan Lovells

Complementary Medicines: the way forward

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According to a recent report published by Grand View Research, Inc., it is expected that by 2026, the global complementary and alternative medicine (CAM) industry will generate over USD 200 billion. The CAM industry, which...more

Hogan Lovells

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

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In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s...more

McDermott Will & Emery

DEA Posts Significant Change to Registration Renewal

McDermott Will & Emery on

The DEA recently posted to its website notice of a significant change to its registration renewal process. This change eliminates the informal grace period which the DEA had previously allowed registrants to renew their...more

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