Guidance on Internet Supply of Non-Prescription Medicines

This guidance outlines the requirements for the internet supply of non-prescription medicines. The aim is to support safe and effective online sale practices of non-prescription medicines by retail pharmacy businesses and non-retail pharmacy businesses entered on the Internet Supply List. 

Guidance on Internet Supply of Non-Prescription Medicines pdf cover

The EU Common Logo was introduced by the Falsified Medicines Directive to fight against falsified medicines.

In order to sell non-prescription medicines over the internet, all websites in the EU must display the Common Logo and be entered in the Internet Supply List of the country from where the website is operated. If selling medicines via the internet in Ireland, you must be authorised by the PSI to be included in the Internet Supply List and to display the Common Logo.

The Common Logo will help members of the public and other bodies identify the websites that are operating legally and provides a link to the Internet Supply List of all authorised pharmacies and retailers displayed on the PSI website.

 

Frequently Asked Questions concerning the legislative requirements for Internet Supply

No. To use the word pharmacy, or to set up an online pharmacy, you must first be registered with the PSI as a Retail Pharmacy Business.

No. The sale of prescription only medicines online are strictly prohibited in Ireland, from a website in Ireland to residents in another country, and to a resident in Ireland from another country. 

In Ireland, only non-prescription medicines are allowed to be sold online. The Internet Supply List is divided into two parts based on the type of retailer: 

Part A of the list contains the registered pharmacies that sell medicines online. Pharmacies selling non-prescription medicines online are allowed to sell the following categories of medicines: 

  • Pharmacy only medicines: These are medicines that can only be sold from a pharmacy under the supervision of a pharmacist, for example, ibuprofen. The list of the pharmacy only medicines not subject to medical prescription is available on the Health Products Regulatory Authority (HPRA) website
  • General sales medicines: These are medicines that can be sold in pharmacies and in non-pharmacy retailers, such as supermarkets and newsagents. For example, paracetamol (maximum pack size of 12 tablets), some cough bottles and certain nicotine replacement therapies. A number of general sales list medicines are restricted to maximum pack sizes, such as paracetamol. The general sales product information list is available on the HPRA website

Part B of the list contains non-pharmacy retailers. These suppliers may only sell general sales list medicines. 

Further information for Internet Suppliers

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.

  • 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. 

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 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. 

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.

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. 

Further information