Internet Suppliers

Information for Internet Suppliers

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• Regulatory Requirements

  The Medicinal Products (Prescription and Control of Supply)(Amendment) Regulations 2015 (S.I. No. 87 of 2015) detail specific requirements in relation to the supply of non-prescription medicinal products over the internet. Some of these requirements are briefly outlined below. More detailed information is available in the PSI Guidance on Internet Supply of Non-Prescription Medicines.

• Supplier Website Requirements

  
  

  The website selling the non-prescription medicinal products must contain the following:

  • The contact details for the PSI, i.e., address, telephone number, email address.
  • A hyperlink to the Internet Supply section of the PSI website.
  • The common logo on every page of the website which relates to the sale of medicinal products online, including a link to the actual Internet Supply List on the PSI website.
  • A statement stating that a record of each transaction will be retained for two years.

• Medicinal Products Requirements

  • You must source your medicinal products from a vendor who holds manufacturer's/wholesale's authorisation of the medicinal product that is granted by an EEA country competent authority. This allows authorising of the manufacture or wholesale distribution of the medicinal products.
  • Medicinal products must be stored and supplied from the fixed premises identified in the application for entry on to the Internet Supply List. In the case of a pharmacy listed in part A of the list, it is required to be a registered retail pharmacy business.
  • Medicinal products must be stored and supplied in accordance with the requirements of the marketing authorisation of the product.
  • The medicinal products supplied in Ireland must be subject of a marketing authorisation from the Health Products Regulatory Authority (HPRA).
  • A website established in Ireland which is registered on the PSI Internet Supply List can supply non-prescription medicines to a purchaser outside of Ireland. The medicinal products supplied must be the subject of a marketing authorisations in the EEA country to which you are supplying. For example, you may only supply a French-authorised medicine pack to a purchaser located in France. It is your responsibility to follow the law of the country that you are selling medicines to.

• Record Keeping Requirements

  
  

  The following records must be kept at the fixed premises identified in the original application for entry on to the Internet Supply List for a period of at least two years from the date of receipt or supply of the medicinal product:

  • Every invoice for a product obtained including:

  1. date of transaction,
  2. name and quantity of product obtained,
  3. name and address of supplier

  • A record of each transaction involving the supply of a medicinal product to the public including:

  1. the order of supply,
  2. date of the transaction,
  3. name and quantity of product supplied,
  4. name and address of the person to whom the product was supplied,

  • A record to show that, in the course of each transaction for supply, prior to supplying to the purchaser and having regard to any previous supply to that purchaser, the person making the supply checks that:

  1. the purchaser is over 18,
  2. the purchaser is aware that the medicinal product should be used in accordance with the recommendations for use contained on the product packaging,
  3. the total quantity of the product supplied in the transaction is a quantity that is reasonable required by the purchaser for his or her personal treatment.

  
  

  Additional Record Keeping Requirements for Pharmacies

  A pharmacy listed in Part A of the list must also keep a record to show that the requirements of Regulation 19 A (7) of the regulations (S.I. No. 87 of 2015) have been complied with. This Regulation states that a pharmacy listed in Part A of the Internet Supply List shall not supply a non-prescription medicinal product to the public over the internet unless, prior to the supply, that the registered pharmacist:

  • personally reviews, supervises and authorises the each order for supply;
  • fulfils the requirements of Regulation 10 of the Regulation of Retail Pharmacy Businesses 2008 (S.I. No. 488 of 2008)

  Regulation 10 of the Regulation of Retail Pharmacy Businesses 2008 (S.I. 488 of 2008) relates to the supply and counselling of patients in respect of non-prescription medicines. It requires that, in the course of the supply, a registered pharmacist is satisfied that the purchaser is aware of what the appropriate use of the medicinal product is, that it is being sought for that purpose and, in so far as the registered pharmacist is aware, the product is not intended for abuse and/or misuse.

• Removal from the Internet Supply List

  You may apply to be removed from the Internet Supply List at any time. You can do this by emailing internetsupply@psi.ie. The PSI may remove a person from the Internet Supply List where they:
  

  • fail to make an application for the relevant 12 month period;
  • fail to comply with the requirements of the regulations;
  • fail to respond to a written request from the PSI seeking confirmation that they continue to offer to sell non-prescription medicines online;
  • have submitted information to the PSI which is false or inaccurate.

• Inspection

  The HPRA and the PSI can carry out inspections of any premises involved in the supply of non-prescription medicines online under Section 32 of the Irish Medicines Board Act 1995 and Section 67 of the Pharmacy Act 2007.

• Breaches of Regulations

  A breach of the Regulations is an offence under Section 32(4) of the Irish Medicines Board Act 1995. The penalties for a breach of regulations on summary conviction are a fine of up to €2,000 or imprisonment for a term of up to one year, or both.

• Other Requirements for Selling Online

  If you sell products to consumers via a website, your website and business must meet certain legal obligations regarding distance selling, eCommerce regulations and data protection requirements. You should refer to the Competition and Consumer Protection Commission website for further information on the requirements for selling products online.

  The Competition and Consumer Protection Commission enforces distance selling and e-commerce regulations and can investigate possible breaches of legislation or consumer rights. You should refer to the Data Protection Commissioner website for further information on your obligations in relation to data protection law.