The Health Products Regulatory Authority (the "HPRA") has recently published updated guidance (the "HPRA Guidance") on the procedure for appealing compliance notices or measures under Regulation 12 and 17 of the European Union (Cosmetic Products) Regulations 2013 (S.I. No. 440 of 2013) (the "S.I."). The updated HPRA Guidance amends the previous version which was published in 2017, in order to clarify decision-making authority within the HPRA for the various enforcement options and in order to modernise and streamline the submission of documentation for oral hearings.
Overview of Current Regime
Under Regulation 18 of the S.I., it is an offence for a responsible person, distributor, manufacturer or natural person to make available on the market a cosmetic product which fails to eg, comply with the safety requirements of Article 3 of the Regulation (EC) No. 1223/2009 on cosmetic products (the "EU Regulations"), take corrective measures to bring a product into conformity with the EU Regulation, or to fail to take effective measures to ensure the recall or withdrawal of a cosmetic product from the market (where there is reason to believe that it is not in conformity with the EU Regulations).
Pursuant to Regulation 12 of the S.I., where an "authorised officer'[1] is of the view that a cosmetic product is not compliant with a requirement under the EU Regulations, he / she may issue a compliance notice setting out the cause of the non-compliance and identifying the corrective actions to be taken. Where appropriate, the compliance notice may also:
- specify a time period in which the corrective actions are to be implemented;
- direct the person on whom it is served to ensure that the cosmetic product is not placed on the market until it has been brought into compliance; and / or
- to inform the assigned "designated person" in respect of that cosmetic product of the corrective actions to be taken.
Where the HPRA forms the opinion that a cosmetic product poses serious risk to human health, the HPRA may take emergency measures to prohibit, restrict or ensure that the product is withdrawn or recalled from the market (pursuant to Regulations 14 and 15 of the S.I. respectively).
Regulation 17 of the S.I. provides for a right of appeal for a person aggrieved by a compliance notice, or measures taken under Regulation 12(9) of the S.I. (ie, to ensure conformity with a compliance notice, emergency measures or provisional measures). Following issuance of a compliance notice (or measures taken pursuant to Regulations 12(9), 14 and 15 of the S.I.), the person on whom it is served has 20 days to put forward his / her viewpoint or to appeal the notice or measures.
Updated HPRA Guidance
The HPRA Guidance is intended to supplement the Regulation 17 right of appeal under the S.I., in line with the principles of "proportionality, fairness, consistency and transparency". In this regard, it provides guidance as to eg, the appeals procedure, the applicable appeal timeframes and the appellant's entitlements to be notified as to the date of the appeal and to be given copies of all documents considered.
The HPRA Guidance provides that appellants should be invited to make a written or oral submission for consideration at the appeal. The appellant must notify the secretary of the appeal committee of their intention to make a written or oral submission no later than 14 days before the date of the appeal meeting. Any written submissions must be provided in both hard copy and electronic format, unless otherwise agreed, and within the dates specified. The HPRA Guidance has been updated so that appellants are required to submit documentation for oral hearings in electronic format only, which cuts out any need to submit hard copy documents for oral representation. The appellant must also inform the secretary of the appeal committee of the number of representatives that will attend the meeting no later than one week before its scheduled date.
The HPRA Guidance specifies that oral presentations should be no longer than 15 minutes, should directly address the subject of the compliance notice or emergency / provisional measures and be delivered in fluent English by representatives having the technical expertise to address any questions raised and managerial authority to take decisions on behalf of the appellant.
The HPRA Guidance has also been amended to include reference to the updated HPRA appeal structure, specifically clarifying who within the HPRA has decision-making authority for the various enforcement options available. Under the updated HPRA Guidance, the decision-making authority is now structured as follows:
- consideration of and decisions regarding appeals submitted in relation to a compliance notice and / or measures taken to ensure conformity with a compliance notice, are taken by the Management Committee of the HPRA. The Management Committee consists of the Chief Executive of the HPRA and all eight HPRA directors; and
- consideration of and decisions regarding appeals submitted in relation to emergency measures and / or provisional measures, are taken by the Authority of the HPRA. The Authority of the HPRA consists of nine members who have been appointed by the Minster for Health.
The appeals procedure and decision making should respect due process and fairness and the appellant should be notified of the outcome within five to seven working days of the meeting.
Next Steps
We note that it will be interesting to see whether any future appeals are publicised and / or appeal outcomes are published by the HPRA. The possible publication of same is not mentioned in the updated HPRA Guidance and there is little to no transparency on what has occurred in the exercise of HPRA's relevant powers in respect of appeals of compliance notices or measures under the S.I. to date.
Matheson’s EU Competition and Regulatory Group regularly advises on all aspect of EU and Irish pharmaceutical and cosmetics issues. If you have any queries, please contact kate.mckenna@matheson.com.
[1]. Being appointed by the chief executive of the HPRA or by the director general of the HSE, or being a customs and excise officer (Regulation 2 of the S.I.).