Maxima Health Research

Maxima Health Research We provide full support for multi-national pharmaceutical and healthcare companies wishing to register their products or which need pharmacovigilance support

The European Commission and EMA have agreed a series of measures to mitigate the impact of disruptions caused by COVID-1...
26/04/2020

The European Commission and EMA have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.

Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related to good manufacturing (GMP) and distribution practice (GDP). The mitigation measures have been taken to ensure the continued availability of medicines while making sure that good practice standards are being adhered to. This is achieved through proportionate approaches to verification of standards by enabling remote assessments of compliance.

For instance, the validity of GMP certificates and time-limited manufacturing and import authorisations, as well as the validity of GDP certificates and time-limited wholesale authorisations will be extended until the end of 2021.

If needed, inspections will be carried out remotely to support such extensions, with on-site inspections carried out as soon as feasible.

The Ministry of Health of the Russian Federation is clarifying the rules for the import of medical devices for registrat...
22/02/2020

The Ministry of Health of the Russian Federation is clarifying the rules for the import of medical devices for registration purposes.

It will now be possible to submit an application in electronic form. The agency has the right to refuse to issue a permit if it finds a discrepancy in the data provided in the registration application.

To obtain permission to import a medical device, the legal entity or individual must submit an application in electronic form, which will indicate the name of the medical device, model, equipment, accessories, quantity, serial number, serial number or batches, production date and expiration date, purpose, name of manufacturer, address of its location and production.

In addition, the application will need to provide complete information about the applicant for the medical device, as well as information about the organizations where it is planned to conduct tests, details of the contract for their conduct, details of the laboratory accreditation certificate.

The applicant must provide a copy of the document confirming the applicant’s authority to register medical devices from the manufacturer.

The regulator will make a decision on the issue of an import permit within five business days.

Good news, the service itself will remain free.

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020. A transition period began on 1 Februar...
08/02/2020

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. This is due to end on 31 December 2020.

The withdrawal agreement establishes the terms of the UK's withdrawal from the EU on 31 January 2020, including a transition period that began on 1 February 2020 and is due to end on 31 December 2020.

During the transition period, EU pharmaceutical law as laid out in the ‘acquis communautaire' will be applicable to the UK.

This means that pharmaceutical companies have until 31 December 2020 to make the necessary changes to ensure that their centrally and nationally authorised medicines comply with EU law and can remain on the EU market.

For example, the following entities can still be located in the UK until 31 December 2020:

* marketing authorisation holders and applicants;
* orphan designation holders;
* qualified persons for pharmacovigilance (QPPVs);
* minor use/minor species (MUMS)/limited markets classification holders;
* companies' manufacturing and batch release sites.

Belarus has approved a procedure to simplify registrations of pharmaceuticals from a number of countries which have stri...
08/02/2020

Belarus has approved a procedure to simplify registrations of pharmaceuticals from a number of countries which have strict regulatory controls.

The Decree #499 dated December 31, 2019 allows a simplified regulatory procedure for medicines registered by authorized bodies of Australia, Austria, the USA, Canada, Switzerland, Japan, the United Kingdom, Germany, Denmark, the Netherlands, Sweden, Spain , and Portugal.

The procedure also applies to medicines registered by the central authority of the European Union under a centralized procedure for use in the above mentioned European countries.

Lastly included are medicines for the treatment of tuberculosis, hepatitis C, HIV infection, and vaccines that have undergone a re-qualification program of the World Health Organization in accordance with the Joint Procedure between WHO / PQT and NRA to assess and accelerate the state registration of WHO-qualified pharmaceuticals.

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