EU GMP Annex 21

Annex 21 to the EU-GMP Guidelines has been published as a draft (on 20^th March 2020), titled "Importation of medicinal Products".

The Annex is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries.

The Annex does not cover products that do not have a marketing authorisation in the EU/EEA and are directly re-exported.

The Annex includes:

·         Physical transfer from the third country to the EU/EEA

·         Certification by the Qualified Person (QP) (link with the requirements of Annex 16)

·         Requirements for equipment and facilities

·         Required documentation

·         GMP requirements for manufacturers and exporters in third countries

·         Qualification and audits under the responsibility of the importing company and the Qualified Person (QP)

·         Import testing

·         Contractual regulations between all companies or persons involved in the import

For details, see: https://ec.europa.eu/health/sites/health/files/files/gmp/importation_medicinalproducts_draftannex21_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Knowing more about a virus threat may not satisfy you

People who rate themselves as highly knowledgeable about a new infectious disease threat could also be more likely to believe they don't know enough, a new study suggests.

In the case of this study, the infectious disease threat was the Zika virus. But the authors of the new study, published recently in the journal Risk Analysis, say the results could apply to the recent novel coronavirus (COVID-19) outbreak.

"The Zika virus and the coronavirus have important things in common," said Shelly Hovick, co-author of the study and assistant professor of communication at The Ohio State University.

"In both cases, they are shrouded in uncertainty and have received a lot of media attention. Our research looks at how people seek and process information when there is so much uncertainty."

One of the key findings of the new study: With limited information about Zika available, more knowledge was not that comforting.

"We found that the more people thought they knew, the more they realized they didn't know enough," said Austin Hubner, lead author of the study and a doctoral student in communication at Ohio State.

"With the Zika virus, even the experts themselves didn't know much at the time. That's the same thing we're seeing with the coronavirus, and that's scary for people who believe they are at risk."

For the study, the researchers conducted an online survey of 494 people of childbearing age living in Florida in December 2016.

See:

Austin Y. Hubner, Shelly R. Hovick. Understanding Risk Information Seeking and Processing during an Infectious Disease Outbreak: The Case of Zika Virus. Risk Analysis, 2020; DOI: 10.1111/risa.13456

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)