European Commission: Amendment to Article 22 of the Delegated Regulation (EU) 2016/161 – Update

As stated on 21st January, EMVO would like to provide you with further details regarding the European Commission’s proposal to amend Article 22 DR (2016).

We can confirm that the European Commission has officially granted a temporary derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom until 31st December 2021.

This new information will be reflected in our Brexit Q&A article shortly.

In case of any questions or uncertainty, please do not hesitate to contact NMVO Support (nmvosupport@emvo-medicines.eu).

Kind regards,

EMVO Team
European Medicines Verification Organisation

www.emvo-medicines.eu

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INTERPOL warns of organized crime threat to COVID-19 vaccines

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LYON, France – INTERPOL has issued a global alert
to law enforcement across its 194 member countries
warning them to prepare for organized crime networks
targeting COVID-19 vaccines, both physically and online.

The INTERPOL Orange Notice outlines potential criminal activity in relation to the
falsification, theft and illegal advertising of COVID-19 and flu vaccines, with the pandemic
having already triggered unprecedented opportunistic and predatory criminal behaviour.

It also includes examples of crimes where individuals have been advertising, selling and
administering fake vaccines.

As a number of COVID-19 vaccines come closer to approval and global distribution,
ensuring the safety of the supply chain and identifying illicit websites selling fake products
will be essential.

The need for coordination between law enforcement and health regulatory bodies will
also play a vital role to ensure the safety of individuals and wellbeing of communities
are protected.

Read more

Finnish customs lead a European wide operation combatting falsified medicines

Finnish customs lead a European wide operation along with Europol and the French Gendarmerie Nationale, combatting falsified medicines. 12 organised crime gangs have been dismantled, which included 165 arrests. The number of arrests in Finland has not been made public, so as not to compromise ongoing investigations. 8 million EUR worth of illegal products were seized, which is around 36 million pills. Both falsified medicines and medicines used for non-prescribed purposes were involved, including cancer medication, antihistamines, analgesics and sleeping tablets. The legal medicine supply chain uses the Finnish Medicines Verification system to ensure falsifications cannot enter the market. Please remember to always buy your medicine from a licensed pharmacy!

Source: FiMVO

Transition period

FAGG/AFMPS has published a communication indicating that the transition period in Belgium will be extended until September 1st.

HOT NEWS

The Belgian Medicines Agency (FAGG/AFMPS) has published a document with practical recommendations for the implementation of FMD

Please find the information here

The Belgian Medicines Agency (FAGG/AFMPS) has published the legislation related to FMD.

You can find the information here (NL) (FR)

 

2D matrix code

Reminder from the Belgian Authorities (Medicines Agency) with regards to the Human Readable text next to the 2D matrix code:

The product code (GTIN) must always be preceded by “PC”

The serial number (UI) must always be preceded by “SN”