European Lawyer Reference: Distribution And Marketing Of Drugs 2013 - Irish Chapter

Author:Mr Colin Kavanagh, Diana Diamond and Caroline O'Gorman
Profession:Arthur Cox

    1.1 What are the legal preconditions for a drug to be distributed within the jurisdiction? Does the drug need to be licensed (authorised) for distribution? Are there exceptions or different categories such as compassionate use?

    The placing of medicinal products on the market in Ireland is regulated by the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, (the 'Marketing Regulations') which implements Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use, as amended by Directive 2004/27/EC. Medicinal products must be authorised prior to distribution. A marketing authorisation (MA) is required from either the Irish Medicines Board (IMB) or, where appropriate, the European Medicines Agency (the EMA). A number of limited exceptions to the requirement for an MA exist, for example, if the drug is intended to be used in a clinical trial and in relation to named patient prescribing.

    1.2 Are any kinds of named patient and/or compassionate use programmes in place? If so, what are the requirements for pre-launch access? (For EU countries only: has Article 5(1) of Directive 2001/83/ EC been transposed by your national legislator?)

    An exemption to the general requirement for an MA exists in respect of the sale or supply of a medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a registered dentist or medical practitioner for use by an individual patient on his direct personal responsibility, in order to fulfill the special needs of that patient (known as the 'named patient regime'). This exemption transposes Article 5(1) of Directive 2001/83/EC. It is subject to a number of conditions, including that:

    the medicinal product be supplied to a registered dentist or medical practitioner or for use in a pharmacy under the supervision of a pharmacist; and no advertisement or representation relating to the medicinal product be issued. There is no system regulating compassionate use programmes in Ireland in the manner envisaged by Article 83 of Regulation 726/2004/EC (whereby groups of patients with a chronic, seriously debilitating, or life-threatening disease for which no satisfactory authorised treatment is available, are granted access to an unlicensed medicinal product). Compassionate use programmes fall under two separate regimes in Ireland:

    (i) the named patient regime (as set out above) which provides access to unlicensed medicinal products to individual patients (rather than groups of patients); and

    (ii) the clinical trial regime–whereby an individual participates in an authorised clinical trial governed by the European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004 (SI 190/ 2004) (as amended)) and thereby gains access to an unlicensed medicinal product.

    1.3 What is the structure of the procedure regarding licensing a drug for distribution? Which national body (agency) is responsible for licensing?

    The IMB is the national body which approves medicinal products for sale in Ireland. In addition, the EMA may (and in certain circumstances must) approve medicinal products.

    An MA may be obtained through the following procedures in each case in accordance with European law:

    National procedure: The application for an MA is made to the IMB. If granted, the MA entitles the marketing authorisation holder (MAH) to place the medicinal product on the Irish market. Mutual recognition procedure: Where a medicinal product has already received an MA in another EEA member state, (the 'Reference Member State' or 'RMS'), a MAH may apply to one or more other member states, (the 'Concerned Member State' or 'CMS'), to recognise that authorisation. Where a product has already received an MA in another EEA state, the MAH can apply to the IMB to mutually recognise that authorisation in Ireland. Decentralised procedure: This procedure may be suitable if the product has not yet received an MA in an EEA state, and the applicant wishes to apply for simultaneous authorisation in two or more member states. The applicant nominates one of the states as the RMS, whose competent authority examines the application in full and prepares a report for the competent authorities of the CMS(s). The IMB is the competent authority for these applications in Ireland. Centralised procedure: A Community MA, which is valid throughout the EEA, may be obtained by applying to the EMA, through the centralised procedure governed by Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency, as amended, (the 'EMA Regulation'). This Centralised Procedure is compulsory for medicinal products developed by means of one of the following biotechnological processes: (i) recombinant DNA technology; (ii) controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; and (iii) hybridoma and monoclonal antibody methods. This Centralised Procedure may also be used for products containing new active substances, products which constitute a significant therapeutic, scientific or technical innovation or products for which the granting of a community authorisation could be in the interest of patients on a community level. 1.4 Is there a simplified licence procedure or are there relaxed licensing conditions for drugs which have already been licensed for distribution in another jurisdiction? What about parallel imports, is there a simplified procedure for these?

    Parallel-importation is the importation from an EU member state or a country within the EEA of a medicinal product which is already authorised on the Irish market, by an importer who is someone other than the importer appointed by the MAH of the product on the Irish market. Two forms of parallel-import license exist. The IMB proscribes that in circumstances where:

    the medicinal product is in any way different to the product...

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