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Another Company recalls its products due to the presence of Nitrosamine impurities

July 6, 2020 Valeriia zhelieva

Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens, and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human…

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Local Person responsible for Pharmacovigilance in Azerbaijan Republic

June 19, 2020 Valeriia zhelieva

Are you aware that Decree of the Cabinet of Ministers of Azerbaijan RepublicNo. 503 on the Rules of Pharmacovigilance of…

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PIC/S adopts cross contamination

June 10, 2020 Valeriia zhelieva

Two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force on 1 June 2020, a questions and answers…

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Global regulators commit to cooperate on observational research in the context of COVID-19

May 22, 2020 Valeriia zhelieva

On 19 May 2020 at a second workshop on observational studies co-organised by the EMA and Health Canada within the…

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50 days to the start of the drug movement monitoring (DMM) system in the Russian Federation

May 13, 2020 Valeriia zhelieva Leave a comment

50 days left to the official start of the all-Russian labelling according to the new requirements of the Decree of…

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National Center for Expertise of Medicines and Medical Devices of the Ministry of Health of the Republic of Kazakhstan approved new standard contract templates

April 30, 2020 Valeriia zhelieva

National Center for Expertise of Medicines and Medical Devices of the Committee for Quality Control and Safety of Goods and…

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Five new guidances posted by the European Commission’s Medical Device Coordination Group

Valeriia zhelieva

The European Commission’s Medical Device Coordination Group posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for…

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Filed under: CER, clinicalevaluation, conformityassessment, MDD, MDR, new regualtory guidance, PMS, PMSF, Remove term: medicaldevices.MDR.MDD medicaldevices

Amended Rules No. 736 “On the Rules of Evaluation of Medicines and Medical Devices” become effective on April 9, 2020 in Republic of Kazakhstan

April 13, 2020 Valeriia zhelieva

Amended Rules No. 736 “On the Rules of Evaluation of Medicines and Medical Devices” become effective on April 9, 2020.…

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Happy Easter holidays!

Valeriia zhelieva

SmartPharma Group wishes this Easter would inspire you to new hope, happiness, prosperity and abundance!

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Suspension of work of the Department of Medicines Supply in Kyrgyz Republic due to COVID-19 pandemic

April 2, 2020 Valeriia zhelieva

The Department of Drug Supply of the Kyrgyz Republic suspends its work from 02.04.2020. Due to the spread of the…

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Recent Posts

  • The Russian side opposed to postpone Implementation period of the EAEU Rules of marketing authorisation December 3, 2020
  • MedSafety app launch in the Kyrgyz Republic November 25, 2020
  • Important amendments to the EAEU legislative acts October 20, 2020

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