Irish Medicines Formulary Online
(IMF-Online) by Meridian Ireland

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Understanding the Irish Healthcare System

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Terminology in Ireland's Healthcare System

Continuing the tour of terminology used in Irish healthcare...

Safety, Regulatory, Legal

HPRA – Health Products Regulatory Authority

Medicines in Ireland are regulated by the HPRA (formerly known as the Irish Medicines Board or IMB) in close collaboration with the European Medicines Agency (EMA).

The HPRA website lists prescribing information (SPC) for all drugs that are licensed in Ireland irrespective of whether they are marketed (i.e. available to prescribe). Exempt medicines and medical devices are not listed.

SPC – Summary of Product Characteristics

The summary of Product Characteristics outlines the conditions under which a medicine is to be used, how it is to be used as well as known safety information. The SPC is sometimes referred to as the License or Full Prescribing Information. Outside of the EU the SPC may be called the Datasheet or Package Insert.
In IMF-Online the SPC is referred to as Full Prescribing Information.

Exempt Medicines

Medicines place on the Irish Market must be authorised by the HPRA or the EMA. However, European Regulations do provide for an exemption to this rule where unauthorised medicines may be supplied if a registered doctor or dentist has prescribed the product for an individual patient under his/her direct responsibility in order to fulfil the special needs of the patient. Such products are defined as ‘exempt medicinal products’ or Exempt Medicines. Exempt medicines are sometimes referred to in Ireland as Unlicensed Medicines or ULMs.

Exempt medicines are clearly marked in IMF-Online:

ULM_Definition

Legal Category

In Ireland, the HPRA regulates the legal category of medicines. Prescription medicines may be categorised as A (subject to prescription which may not be renewed), B (subject to prescription which may be renewed) or C (product subject to restricted prescription).

The UK uses POM to denote prescription only medicines and some non-EU countries have more complex medicine scheduling e.g. South Africa which has 6 schedules.
In IMF-Online the legal category is stated in the line of the brand name:

POM-Definition

Interchangeability – Generic Substitution

In Ireland generic substitution allows pharmacists to substitute a less expensive generic equivalent (from the published list of Interchangeable Medicines), when a more expensive product has been prescribed.

The HPRA establishes, publishes and maintains a list of interchangeable medicines i.e. those medicines that:

  • contain the same active ingredient and strength
  • are in the same pharmaceutical form
  • have the same route of administration

Interchangeable brands i.e. same strengths of all brands of the same formulation deemed interchangeable, are highlighted in IMF-Online under each specific molecule, where applicable:

Generic_Substitution

We hope you found these sample extracts from IMF-Online informative and look forward to your subscription to this world-class medicines information repository.

 

 

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