Exempt Medicinal Products, commonly known as “EMPs,” are provided “in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients”. Unlike authorised medicinal products, which generally need to be imported with a MIA if sourced from outside the EU/EEA, EMPs can be imported under a WDA even from non-EU countries, provided that the activity fully complies with the HPRA’s Guide to Exempt Medicinal Products.
In accordance with the guidance provided by the Health Products Regulatory Authority, a WDA holder is permitted to procure exempt medicinal products (EMPs) directly from both within and/or outside European Economic Area under their WDA. It is imperative, however, that they exercise caution by:
- Ensuring that all activities conducted fall within the specific scope of a WDA that encompasses the handling of exempt products as a recognized category.
- Ensuring that appropriate justification from the prescriber is obtained and retained – The supply of an exempt product must always be initiated by a healthcare professional who assumes full responsibility for the treatment. It is crucial to recognize that an exempt medicinal product cannot be prescribed or dispensed in cases where an authorised equivalent (defined as having the same active substance(s), strength and dosage form) is available in Ireland. This is in accordance with the judgement in European Court of Justice case C-185/10 Commission v Poland.
- Only supply EMPs to entities authorised to distribute them in Ireland, such as a retail pharmacy or Irish hospitals.
- The only exception to this rule is, if the entity that imported the EMP under its WDA is supplying a secondary WDA holder who is authorised to distribute EMPs provided that the importing WDA holder can demonstrate sufficient control and oversight to ensure that the imported EMP will remain on the Irish market and will not be supplied outside of the state. A declaration from a proposed wholesale customer is not considered sufficient oversight.
- The HPRA also requires that exempt medicinal products are notified of the procurement and/or receipt to the HPRA EMP Database prior to their supply, especially where the product falls into specific categories such as controlled substances or high-risk active ingredients. Distributors must be aware of these obligations and ensure that notifications are submitted in a timely manner to avoid regulatory non-compliance.
It is essential to clearly understand the distinction between what is permitted under a WDA and what requires an MIA. While EMPs can be imported from outside the EU/EEA under a WDA, this is a unique allowance and does not extend to authorised medicinal products, which always require QP certification and an MIA for third-country importation. Incorrectly classifying a product or not fulfilling EMP requirements can result in significant compliance issues.
In conclusion, the importation of Exempt Medicinal Products under a WDA provides an important mechanism to address unmet patient needs, but it comes with clearly defined responsibilities. Adhering to the expectations set forth by the HPRA, especially in relation to documentation, monitoring, and supply chain management is essential to operate within this exemption.
If your organisation is currently importing or planning to import Exempt Medicinal Products under a Wholesale Distribution Authorisation, now is the ideal time to review your procedures. Ensuring compliance with HPRA expectations—particularly around prescriber documentation, supply chain verification, and proper product categorisation—is essential to avoid regulatory risk. At Acorn Regulatory, we are available to support you in assessing and adapting your existing procedures to align with current requirements. Whether you need a compliance check, procedural updates, or tailored guidance for your Responsible Person, we are here to help you strengthen your quality system and stay inspection ready. If you would like to speak to one of our RPs regarding EMPs or general importation of products, please get in contact via our email: enquiries@acornregulatory.com.
