The primary source of obligations regarding cosmetic products on pharmacies in Ireland, is the EU Cosmetic Products Regulation (EC) No. 1223/2009 (the “EU Regulations”) which was transposed into Irish law by the European Union (Cosmetic Products) Regulations 2013 (S.I. No. 440/2013) (the “Irish Regulations”). Taken together these pieces of legislation govern the manufacture, supply and sale of cosmetic products in Ireland. Pursuant to the Regulations, the Competent Authority for the implementation and oversight of these regulations in Ireland is the Health Products Regulatory Authority (HPRA).

Key points:

• “Cosmetic product” is widely defined and includes many products sold in pharmacies and includes deodorants, soaps, perfumes and any product that comes in contact with the human body;
• Pharmacists/pharmacies come within the definition of “distributor”;
• In certain circumstances a distributor may be considered a “Responsible Person” for a cosmetic product placing that distributor into the role of the entity placing the product on the market;
• Distributors are subject to certain obligations as set out in Article 6 of the EU Regulations and Parts 3 and 4 of the Irish Regulations; and

The HPRA is the Competent Authority in Ireland in relation to these Regulations. Authorised Officers within the HPRA and the HSE have powers to enter and search any premises where manufacture, distribution or supply of a cosmetic product may be taking place including pharmacies.

Definition of “cosmetic product”

A cosmetic product is defined as, “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.

This is quite a wide definition, which includes (but is not limited to), products such as deodorants, shampoos, soaps and shower gels, hair dyes, hair removal products, perfumes and toothpastes, as well as make-up and skincare products. Pharmacists should also be careful with regard to any “home remedies” for topical application, which may have been compounded in the pharmacy.

Definition of “distributor”

Under the Irish Regulations, distributor means, “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the market in the European Economic Area and includes the person engaged in the retail sale or supply of the cosmetic product whether for payment or otherwise” (emphasis added).  

This definition applies to pharmacies/pharmacists in the normal course of business where the pharmacy obtains products that fall within the definition of “cosmetic product” from a third party and the pharmacy stocks and sells the product. As distributors, pharmacies/pharmacists are obliged when stocking these types of product, to ensure that they are satisfied that it is appropriate for the product to be sold in the pharmacy. In practice this means being satisfied, in a reasonable manner, that the product meets the requirements under the Regulations or, for example, that they have not received product from a supplier intended for a non-EEA market in error.

The Responsible Person

Article 4 of the EU Regulations state that “[o]nly cosmetic products for which a legal or natural person is designated within the Community as “responsible person” shall be placed on the market”. The responsible person, “shall ensure compliance with the relevant obligations set out in this Regulation”.

Generally, the manufacturer of a cosmetic product is considered to be the Responsible Person. However, the distributor is the Responsible Person where they place a cosmetic product on the market under their name or trademark, or where they modify a product already placed on the market in such a way that the compliance with the applicable requirements may be affected — for example, re-labelling a product with their own name and contact details. This would also apply to “home remedies” compounded in the pharmacy and sold to the public.

Key responsibilities

The Responsible Person has a number of key responsibilities including:

• Notify the European Product Portal of the placing of the product on the EU Market;
• To ensure that the product poses no harm to humans;
• To maintain certain information specified in Article 11 of the EU Regulations;
• To ensure the product has undergone a safety assessment;
• Ensure records are kept of any such assessment for future reference by a Competent Authority;
• To take responsibility for any undesirable effects of the product including contact with Competent Authorities, conducting recall etc; and
• Take all necessary steps to ensure that the product complies with these Regulations including in respect of labelling and packaging and any other required measures.

This is a summary of the key responsibilities, however if a pharmacist is of the view that they may fall within the category of a Responsible Person, it would be prudent to contact the IPU with a view to obtaining advice and assistance in relation to this.

In addition, care should be taken when importing products from outside of the EEA and placing them for sale. In such instances, this would fall within the definition of the product being “placed on the market” and would thereby place the pharmacy/pharmacist in the position of a “Responsible Person”.

Therefore, when considering whether a product, not usually on sale in the market, should be stocked and sold by the pharmacy/pharmacist, the pharmacist should consider the following, along with consideration of other aspects such as compliance with PSI guidelines and guidelines issued by the HPRA:

• If the supplier is located outside the EEA, the pharmacy/pharmacist may fall into the category of not only a distributor but also an importer, and therefore would be considered a Responsible Person;
• If it seems the pharmacy/pharmacist may fall into the category of an importer, a check should be performed to identify if the product labelling lists a European contact. If so, this may ensure they are not considered the Responsible Person; and
• If a European contact is present, they should be contacted to confirm that this person is the Responsible Person for the product in question, and to notify the Responsible Person that you are importing the product into the EEA. This step should be carried out in written correspondence (i.e. letter, email etc), so a full paper trail exists should proof be required that this contact is the Responsible Person. If there is no European contact listed and the importer (in this case a pharmacist) proceeds to place the product on the market regardless, then this importer (i.e. the pharmacist), takes on the role of Responsible Person.

Obligations of distributors

In stating all of the above, in the normal course of events, most pharmacies/pharmacists will fall within the category of a “Distributor”. Article 6 of the EU Regulations places the following obligations on distributors:

• To act with due care in relation to applicable requirements (as set out below and in Article 6 of the Regulations);
• To verify that labelling information is present and that language requirements are fulfilled (i.e. the labelling contains a description of the characteristics of the product including ingredients and where this is not practical an information leaflet is included), that the labelling is easily understood and that it is in the English (or both English and Irish) language;
• To verify that the date of minimum durability specified (where applicable) has not passed (i.e. that the product is not past its “sell by” or “use by” date);
• To take corrective measures to bring a con-compliant product into compliance, if possible. For example, where an information leaflet is not provided but should be, if the pharmacist is comfortable to, provide an information leaflet with the product. By way of example this may be done by perhaps photocopying an information leaflet for the exact same product and supplying the copy;
• To take preventative measures where relevant. By way of example, where the pharmacist becomes aware that the product is not in compliance with the Regulations, to consider placing a notice in the pharmacy of this fact and identify how the non-compliant product can be returned.;
• To notify the Responsible Person and the HPRA where a product poses a risk;
• To ensure that storage or transport conditions do not negatively impact the product’s compliance while under their responsibility; and
• To cooperate with the HPRA (as the Competent Authority).

Conclusion

While it is relatively normal practice for pharmacies to stock cosmetic products, doing so places certain onuses on pharmacies and pharmacists to ensure that the products on sale in the pharmacy are compliant with the basic requirements of both EU and Irish Regulations and to cooperate with the HPRA in respect of any issues arising with a product sold in the pharmacy. In stating this however, we are mindful of the fact that pharmacies/pharmacists are already under such obligations in any event in respect of pharmaceutical products.

Pharmacists should exercise caution where products are introduced to them or where they wish to stock certain products in the pharmacy, which are new to them or those that they are unfamiliar with. Care should be taken to establish the identity of the Responsible Person in relation to these products in order to avoid falling into the category of the Responsible Person themselves, which places additional burdens on pharmacies/pharmacists.

About the authors: Niall Sexton and Beth Bolger are Senior Associates in DAC Beachcroft Dublin Regulatory, Professional & Public Law team which is led by Gary Rice, Partner. DAC Beachcroft has advised the IPU and its members for many years and specialises in the legal aspects of pharmacy practice. For more information, please contact Niall or Beth.  For more information on any legal aspect of pharmacy practice, please contact Gary Rice.