Pharmaceutical Drug Product Registration in Ireland

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.

License Validity

      5 Years

Registration Fee 

      22,570 Euro