If you are an online seller of medicinal products in EU, then you are directly affected by the EU Falsified Medicinal Products Directive 2011/62/EU.
From 1st July 2015, all online pharmacies or retailers of medicines legally operating in the European Union should display a new logo introduced by the Directive 2011/62/EU. Click here to downlaod the Directive.
The Directive requires all pharmacies and other businesses selling medicinal products to the public online to register in a national list of registered sellers, and to display a common (European) logo on the websites offering their medicinal products for sale. In UK, this list is maintained by the Medicines and Healthcare products Regulatory Authority (MHRA). The MHRA will make the common logo available upon successful registration.
The MHRA has invited the UK-based sellers to find out more about the common logo registration using the link below:
https://pclportal.mhra.gov.ukhttps://pclportal.mhra.gov.uk
If you reside in UK and sell medicines to the public on a website, you must register with MHRA. New applications will take up to 90 working days to complete the process. This does not include the time taken to provide further information. MHRA will verify the information provided.
When the registration is completed, you will receive a confirmation email with the following link to download the EU common logo:
https://www.gov.uk/register-for-the-eu-common-logo
If you reside in another EU Member State, you must register with the relevant regulatory authority in that Member State.
Amazon has taken this directive into serious consideration. In terms of the new Falsified Medicinal Products Directive, Amazon is preparing to add the common logo to the detail pages of the medicinal products offered through the Amazon website.
What does this mean for you as a seller of medicinal products?
1) Please contact your competent regulatory authority to inquire as to how you can register in the national list of registered sellers. For UK-based sellers, the relevant authority will be the MHRA.
2) Once registered, you will need to:
– provide the hyperlink to your entry in the national list to all your on-line distributors and
– revise the attributes for your offers for medicinal products in their pages
so that your products can be linked with the legally required common logo.
If you would like consultant or freelancer support with registering your business and obtaining of common European logo, please post the job at Pharmaceutical Outsourcing Network
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