IRISH LEGISLATION PERTAINING TO MEDICINES

Under Irish legislation all medicinal products must be authorised before being marketed. Before such an authorisation can be obtained legal requirements regarding the safety, quality and efficacy of the medicine concerned must be met.

In Ireland, law regarding the production, quality assurance, packaging, import and export of medicines is spread across numerous pieces of legislation. Many of the laws pertaining to medicines now on the Irish statute book were enacted specifically to give effect to EU Directives. For example Directive 726/2004/EC is specifically concerned with the coordination of the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and with other aspects of the supervision of authorised medicinal products in use in the European Community. Irish legislation is based on these provisions and gives legal effect to them within the jurisdiction.

In Ireland the agency with responsibility for overseeing and ensuring the standards required in law is the Irish Medicines Board (IMB). The role of the Board is defined in the Irish Medicines Board Act of 1995 and in the Irish Medicines Board (Miscellaneous Provisions) Act 2006 which amends or updates parts of the 1995 Act. Notably the latter establishes the role of the Irish Medicines Board   “to establish and administer a service for the receipt of applications from persons proposing to export any description of medicinal products.” The IMB has responsibility for issuing a whole range of licences/certificates without which the manufacture, sale, importation and exportation of Medicines cannot legally take place. It also operates systems that monitors quality assurance and certifies the Good Manufacturing Process compliance of manufacturing sites. Certificates issued by the IMB follow World Health Organisations recommendations as do those issued in other EU countries. The fact that much of Irish law is based on EU Directives and that certification follows WHO recommendations indicates a movement towards the standardization of medicines quality control across EU countries.

IRISH LAW: While there are numerous pieces of legislation on the Irish Statute Books one, the Medicinal Products (Control of Manufacture) Regulations 2007 is the most relevant in ascertaining the standards required for the manufacture, sale and export of medicines. The provisions of this law contain comprehensive and strong regulations regarding the quality of medicines produced in Ireland or imported to Ireland. This law also covers the packaging, labelling and export of medicines. In addition it legislates for enforcement and inspection procedures, the revocation or suspension of a manufacturer’s authorisation and the withdrawal of a product from, production, sale and exportation if a medicine is found not to conform to safety standards as regards strength, quality or purity.

This law requires that Manufactures meet good manufacturing practice (GMP) and quality control standards. Medicines imported into Ireland are expected to meet the same standards and must undergo a full qualitative analysis. From this it appears that all medicines whether produced in Ireland or imported must meet GMP requirements and the standards It would appear that since the same standards apply to medicines imported and produced in Ireland then those exported should also be of the same standard. During research for this Report no obvious loophole allowing the production or export of poorer quality medicines became evident. However this does not mean that such loopholes do not exist. Further research through discussions with individuals who are au fait with the law and manufacturing practice are needed to establish if there are exemptions to the legislation outlined above that allow for the manufacture or export of medicines that are of a lower standard that those used in Ireland.