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Pharmaceutical /Medicine/Drug/OTC registration in Ireland

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Pharmaceutical /Medicine/Drug/OTC registration in Ireland

Pharmaceutical /Medicine/Drug/OTC registration in Ireland

MOH –Department of Health 

 MOH Website- https://www.gov.ie/ 

 Regulatory Authority- The Health Products Regulatory Authority (HPRA) 

 Regulatory Website- https://www.hpra.ie/ 

 Local Authorized Representative Required- Yes  

Classification of Medicine 

Herbal Medicine  

Herbal medicinal products are defined as pharmaceuticals having one or more herbal preparations, one or more herbal substances, or one or more of these substances combined with one or more herbal preparations as active components. 

Homeopathic Medicine  

In compliance with the provisions of Directive 2004/27/EC, Member States that recognize their tradition of homeopathic practice may apply specific regulations to homeopathic medicines, which are unique forms of medicinal products. The Medicinal Products (Control of Placing on the Market) Regulations (S.I. 540 of 2007), which were created under the Irish Medicines Board Acts of 1995 and 2006, give this Directive legal force in Ireland.  

Drug Approval Process 

  • Centralized Process- A business in the European Union (EU) may apply to the European Medicines Agency (EMA) through the centralized procedure for a single marketing authorization that is accepted by all EU members as well as Iceland, Liechtenstein, and Norway. It is required for several types of medications to employ this licensing system, such as:  
  • medications with novel active ingredients used to treat specific ailments (AIDS, cancer, diabetes, and others) 
  • medications for advanced therapy 
  • pharmaceuticals produced using biotechnology pharmaceuticals 
  •  uncommon human illnesses (sometimes referred to as “orphan medicines”) 
    • Decentralized Process 

     A business does not need to use the centralized method to approve a drug that has not yet received approval in any EU nation to apply for marketing authorization through the decentralized procedure (DCP).  

     If a pharmaceutical already has a marketing authorization in one Member State and the company wants to promote it in other Member States, they can use the mutual recognition procedure (MRP). 

    The corporation chooses which EU nations to apply for marketing authorization for the DCP and the MRP. To oversee the process and evaluate the marketing authorization application on behalf of the other participating Member States, one of those nations serves as the Reference Member State (RMS). The remaining Member States are later known as Concerned Member States (CMSs), and they have the right to comment on the application throughout the process.  Every Member State participating in the process issues a marketing authorization to the company if the application is granted at the conclusion of the process. 

    • National Process 

    If a business just wants to market a medication in Ireland and the product in issue does not need to be approved through the centralized procedure, it can apply directly to the HPRA for a marketing authorization. The Mutual Recognition Procedure can be used if the same corporation decided later that they would like to commercialize the medication in another EU Member State. 

    Renewal of Application 

    After the date of initial issuance, marketing authorizations are valid for five years. At the end of these five years, the authorization must be renewed to be valid. After this renewal, the authorization is still in effect indefinitely (unless the HPRA determines that additional renewals are required for reasons related to drug safety). 

    To facilitate a common renewal date for a range of products or for products within the Mutual Recognition procedure that may have been authorized at different times in different Member States, earlier renewals are acceptable. Renewal applications must be submitted to the HPRA at least nine months before the authorization expires. The common renewal date should be agreed upon with the Reference Member State. 

Certificate For Export 

 All applications received should include: 

  • Completed and signed Application for an Export Certificate 
  • Proof of payment 
  • Where required they should also include the completed draft document
  • Where included attachments such as composition tables or patient information leaflets 
  • Must be accompanied by a letter stating that the information in them is true and correct 
  • There is no requirement to submit a Summary of Product Characteristics, if one is required to be attached to a CPP, simply note this on the draft and we will attach the latest approved version from our record.

Pharmacovigilance  

 The legal basis for pharmacovigilance for medicines for human use in the EU is laid down in Directive 2001/83/EC and Regulation (EC) No 726/2004, as amended. The most recent amendments to this legislation in 2010 were implemented to further protect public health by strengthening the European-wide system for monitoring the safety of medicines 

Marketing authorization holders (MAHs) must make sure that a suitable pharmacovigilance system is in place to take responsibility for marketed medicines and to guarantee that appropriate action may be taken, when necessary, in accordance with relevant EU guidance included in GVP, as required by both European and national legislation. 

It is customary to notify the MAH or pharmacovigilance service provider four to six weeks before the scheduled inspection date. If necessary, the HPRA has the authority to give less warning or carry out an unexpected examination. A maximum of two weeks prior to the inspection date, the inspected is often inspected plan outlining the general areas to be covered and the time scheduled for conducting inspection operations. 

A pharmacovigilance document called a Periodic Safety Update Report (PSUR) is designed to assess the risk-benefit balance of a pharmaceutical product at specific intervals after authorization. Presenting a thorough and critical review of the product’s risk-benefit balance while accounting for newly discovered or developing safety information in the context of accumulated risk and benefit data is the aim of the PSUR. 

Regulation (EU) No 1235/2010, Directive 2010/84/EU, and Commission Implementing Regulation (EU) No 520/2012 provide forth the legal prerequisites for PSUR submission. The structure of PSURs is outlined in Implementing Regulation Article 35, and the Guidelines on Good Pharmacovigilance Practices (GVP) offer guidelines on how to prepare, submit, and evaluate PSURs in Module VII. 

  Normally, before to the inspection, the following information is requested: 

    • a current Pharmacovigilance System Master File (PSMF) version. 
    • lists or organization charts of the important individuals engaged in pharmacovigilance operations. 
    • Documented protocols and procedures associated with the pharmacovigilance system 

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