Requirements for online sale of medicinal products
Online sales of medicinal products in the EU are subject to regulation. This material summarises:
- the EU requirements , and
- the UK requirements following Brexit, both before and after the end of the transition period (December 31, 2020).
This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your product. This material only reflects the position at the date of writing and requirements in the EU and the UK and may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (where available) to learn more about changes that may affect you following the end of the transition period.
l. EU requirements
Online sellers of medicinal products are directly affected by the EU Falsified Medicinal Products Directive 2011/62/EU.
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 the EU common logo on the websites offering their medicinal products for sale.
We would like to remind you that the sale of medicinal products is only allowed on Amazon.de. For more information on local regulation, visit the following websites:
- Europe: Pharmaceutical and cosmetic products (English)
- Germany: BFARM - Medicinal Products (English)
If you are established in another EU Member State, you must register with the relevant regulatory authority in that Member State.
Amazon is adding the common logo to the detail pages of medicinal products offered through Amazon.
It is your responsibility to comply with the EU Falsified Medicinal Products Directive 2011/62/EU If you sell these products on Amazon EU website(s). You must also comply with national laws and regulations in EU Member States, which implement the EU Falsified Medicinal Products Directive 2011/62/EU.
What products do the EU requirements cover?
The EU requirements apply to “medicinal products” as defined in Directive 2001/83/EC, which includes:
- any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
-
any substance or combination of substances that may be used by or administered to human beings with a view to—
- restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
- making a medical diagnosis.
What does this mean for you as a seller of medicinal products on Amazon EU websites?
- Contact your relevant regulatory authority to enquire as to how you can register in the national list of registered sellers of medicinal products. Other regulatory authorities are listed on this website.
-
Once registered as a seller of medicinal products, you can provide Amazon with the URL to your entry in the national list by doing the following:
- Sign in to your Seller Central account.
- Go to Settings at the upper-right of the page, select Account Info, then click Your Seller Profile on the top left section of that page.
- Click the Edit button for a specific marketplace or the link to Edit Information for All Marketplaces.
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Enter your URL in the EU Common Logo Register URL field.
Verify your URL starts with one of the following domains:
- https://versandapotheken.basg.gv.at
- http://www.fagg-afmps.be
- https://www.sukl.cz
- https://sundhedsstyrelsen.dk
- https://ravimiamet.ee
- http://www.fimea.fi
- http://www.sante.gouv.fr
- https://versandhandel.dimdi.de
- http://www.ogyei.gov.hu
- http://www.thepsi.ie
- https://www.zva.gov.lv
- https://www.aanbiedersmedicijnen.nl
- http://ra.rejestrymedyczne.csioz.gov.pl
- https://distafarma.aemps.es
- https://lakemedelsverket.se
- http://www.salute.gov.it/
- Make sure all of your medicinal product listings have the attribute ‘medicine_classification’ populated with a value (should not be left empty), so that your products can be linked with the legally required common logo.
ll. UK requirements:
Online sellers of medicinal products for human use in the UK must comply with the UK’s Human Medicines Regulations 2012/1916 (the “UK HMR”), which implement the EU Falsified Medicinal Products Directive 2011/62/EU.
The UK HMR 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 the EU common logo (or “distance selling logo”) on the websites offering their medicinal products for sale. In the UK, this list is maintained by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA will make an individualised common logo URL available to you upon successful registration.
The MHRA has invited UK-based sellers to find out more about the common logo registration process using this link.
If you reside in the UK and sell medicines to the public online, you must register with the MHRA. The process for new applications can take up to 90 working days to complete, not including the time taken to provide further information. The MHRA will verify the information provided. For more information, click here.
After the end of the Brexit transition period (December 31, 2020), there will no longer be an obligation to display the EU common logo on websites offering medicinal products for sale in the UK. The UK Government has suggested it may introduce a UK-specific logo in the future, but details of this have not been published at the time of writing. You should refer to current UK guidance on Brexit in relation to changes that may affect your products following the end of the transition period.
It is your responsibility to comply with the UK HMR for medicinal products sold in the UK. If you also sell these products on Amazon EU website(s) then you must also comply with national laws and regulations in EU Member States, which implement the EU Falsified Medicinal Products Directive 2011/62/EU.
What products do the UK requirements cover?
The UK HMR apply to “medicinal products” which include:
- any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
-
any substance or combination of substances that may be used by or administered to human beings with a view to—
- restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
- making a medical diagnosis.
What does this mean for you as a seller of medicinal products on Amazon.co.uk?
Amazon is adding the common logo to the detail pages of medicinal products offered through Amazon. If you sell medicinal products through Amazon.co.uk, you must take the following steps:
- Contact the MHRA to enquire as to how you can register in the national list of registered sellers of medicinal products. For UK-based sellers, the relevant authority will be the MHRA.
-
Once registered as a seller of medicinal products, you can provide Amazon with the URL to your entry in the national list by doing the following:
- Sign in to your Seller Central account.
- Go to Settings at the upper-right of the page, select Account Info, then click Your Seller Profile on the top left section of that page.
- Click the Edit button for a specific marketplace or the link to Edit Information for All Marketplaces.
- Enter your URL in the EU Common Logo Register URL field.
- Verify your URL starts with the following domain.
- Make sure all of your medicinal product listings have the attribute ‘medicine_classification’ populated with a value (should not be left empty), so that your products can be linked with the legally required common logo.
Additional Information
For more information on UK requirements, visit the following UK Government websites:
- https://www.gov.uk/guidance/register-for-the-distance-selling-logo
- https://www.gov.uk/government/collections/mhra-post-transition-period-information
We also encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules.
