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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers – implications for QPs

  • 29 August 2019
  • agreement, batch, consequence, EC, EU, FDA, GMP, human, implication, inspection, manufacturer, manufacturing, medicines, milestone, MRA, Mutual Recognition Agreement, phase, QP, site, testing, transition, US, USA, waiver,
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. It means that the US Food and
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The exemption from EU batch re-testing for imported ATMPs

  • 27 August 2019
  • 11.17, applicant, ATMP, authorised, autologous, batch, control, country, EEA, EMA, EU, exemption, GMP, guidelines, import, MA, MAH, paragraph, patient, product, Q&A, QP, quality, re-testing, section, specific, third,
On 21 August 2019 EMA has published document entitled Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country. The exemption from re-testing batches upon import into the EU for authorised ATMPs may only be granted where the conditions laid down in paragraph
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The first cannabidiol containing medicinal product with a positive opinion in the EU centralised procedure!

  • 22 August 2019
  • cannabidiol, cannabis, CBD, centralised procedure, CHMP, clobazam, CP, Dravet syndrome, DS, EMA, Epidyolex, epilepsy, EU, GW Pharma (International) B.V., Lennox-Gastaut syndrome, LGS, MA, MAH, marketing authorization, medicinal product, oral solution, orphan designation, orphan medicine, seizures,
On 25 July 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Epidyolex, intended for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), two forms of epilepsy. The applicant for this medicinal product is
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