Medicines, Controlled Drugs and Pharmacy Legislation Unit

Medicines, Controlled Drugs and Pharmacy Legislation Unit develops policy and legislation in relation to medicines, cosmetics, poisons, controlled drugs and pharmacy services.

The Unit engages at EU and international level in relation to the development and implementation of pharmaceutical policy and medicines legislation.

Medicines Section
Pharmacy Legislation and Regulation Section
Controlled Drugs Legislation Section

Medicines

Key objectives

To ensure that an appropriate legal framework, policies and relevant structures are in place to protect the health and safety of the public with regard to medicinal products, cosmetic products, poisons and medical devices; including contributing to policy development at EU and international level.

Reponsibilities:

Responsible for the development of policy with regard to medicinal products, medical devices, clinical trials, cosmetics and poisons,
Transposition of relevant EU legislation,
Participation in EU Working Groups and Standing Committees and in international meetings
Monitoring and evaluating the work of the Irish Medicines Board, the statutory agency responsible for the regulation of human and veterinary medicines, cosmetics and clinical trials in Ireland.

Agencies
Other Related Bodies
Legislation

Medicinal Products
Medical Devices
Cosmetics

Useful Links
Section 15 of FOI Act
Contact this Division

Agencies

Irish Medicines Board www.imb.ie

The Irish Medicines Board (IMB) protects and enhances public and animal health through the regulation of human and veterinary medical products. Among the IMB’s areas of responsibility are regulation of clinical trials, as well as monitoring and inspecting products on the market to ensure their safety and efficacy. The IMB is the Competent Authority for the implementation of EU and national legislation relating to Blood and Blood Components, Tissue and Cells, Medicinal Products, Medical Devices and Cosmetics.

Other Related Bodies

The European Medicines Agency www.ema.europa.eu

The European Medicines Agency (EMA) is the European Union body responsible for coordinating the evaluation, supervision and pharmacovigilance of medicinal products at EU level. The Agency provides the Member States and the institutions of the EU with scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products.

European Commission

The European Commission Directorate General for Health and Consumers (SANCO) Pharmaceuticals Unit has responsibility for medicinal product regulation:

Medicines

The European Commission Directorate General for Health and Consumers (SANCO) Cosmetics and Medical Devices Unit has responsibility for cosmetics and medical devices:

Cosmetics

Medical Devices

Section 15 of FOI Act

Record Classes N/A

Significant Systems N/A

Personal Information Holdings N/A

Purpose N/A

Disclosees N/A

Notes: including information on admin access practice, Ebriefs etc: Standard policy and briefing documentation

Contact this Division

Contact this Unit

Staff:

Chief Pharmacist: Marita Kinsella

Assistant Principals: Mary Dowling

Pharmacist: Noreen Quinn

Tel. No. 01-6354000

Email medicines_unit@health.gov.ie

Pharmacy Legislation and Regulation Section

Key Objectives

To develop and implement policy and legislation in relation to the regulation of pharmacists and pharmacies, including the development of pharmacy education and training policy and the professional role of the pharmacist in the healthcare system.

Reponsibilities:

To input into the development of the professional role of pharmacists, including education and in the context of the development of pharmacy services.
Oversight of the regulation of pharmacists and pharmacies and the implementation of the Pharmacy Act 2007 as amended.
Monitoring of the Pharmaceutical Society of Ireland, including governance and operations under the Pharmacy Act 2007.
Chairing the Medication Safety Forum which has taken up the role of implementing the medication safety recommendations of the Report of the Commission on Patient Safety “Building a culture of patient safety’’.

Agencies and other Relevant Bodies
Legislation
Useful Links
Section 15 of FOI Act
Contact this Office

Agencies and other Relevant Bodies

The Pharmaceutical Society of Ireland (PSI) www.thepsi.ie

The PSI was established under the Pharmacy Act 2007 as the pharmacy regulator to act in the interests of patient safety and public protection.

The main role of the PSI includes:

registration of pharmacists and pharmacies;
handling complaints and disciplinary matters, including fitness to practice and the imposition of sanctions;
inspection and enforcement of pharmacies, including the taking of prosecutions;
accreditation of educational programmes for the pharmacy profession;
actions to improve the profession of pharmacy;
quality assurance of standards, and the development of pharmacy practice;
provision of advice to the Government on pharmacy care, treatment and service in Ireland.

Legislation

Pharmacy Act 2007 (No. 20 of 2007) as amended by the (European Communities (Recognition of Professional Qualifications relating to the profession of pharmacist) (No. 2) Regulations 2008, S.I. No. 489 of 2008)

http://www.oireachtas.ie/documents/bills28/acts/2007/a2007.pdf

http://www.dohc.ie/legislation/statutory_instruments/pdf/si20080489.pdf?direct=1

Regulation of Retail Pharmacy Businesses Regulations 2008, S.I. No. 488 of 2008

Pharmaceutical Society of Ireland (Council) Rules 2008, S.I. No. 492 of 2008

Pharmaceutical Society of Ireland (Education and Training) Rules 2008, S.I. No. 493 of 2008

Pharmaceutical Society of Ireland (Registration) Rules 2008, S.I. No. 494 of 2008

Pharmaceutical Society of Ireland (Retail Pharmacy Businesses) (Registration) Rules 2008, S.I. No. 494 of 2008

Pharmaceutical Society of Ireland (Fees) Rules 2008 and 2010, S.I. 496 of 2008 as amended by S.I. No. 257 of 2010

http://www.irishstatutebook.ie/2008/en/si/0496.html

http://www.irishstatutebook.ie/2010/en/si/0257.html

Useful Links

www.thepsi.ie

Section 15 of FOI Act

Record Classes N/A

Significant Systems N/A

Personal Information Holdings N/A

Purpose N/A

Disclosees N/A

Notes: including information on admin access practice, Ebriefs etc: Standard policy and briefing documentation

Contact this Unit

Staff:

Chief Pharmacist: Marita Kinsella

Assistant Principals: Eddie Quigley

Pharmacist: Noreen Quinn

Tel. No. 01-6354000

Fax No. 01-6354369

Controlled Drugs Legislation Unit

Key Objectives

To develop and implement policy and legislation on the control of drugs and precursor substances in accordance with national policy and international conventions, and to maintain the Misuse of Drugs legislation as fit for purpose.

Reponsibilities:

Regulation of controlled drugs and precursor substances under Misuse of Drugs legislation, and EU legislation including the control of new psychoactive substances.
Maintaining the Misuse of Drugs legislation as fit for purpose.
Authorising supply of methadone scripts to GPs and supply of methadone to pharmacies for palliative care.
Processing of Import/Export Licences etc. for controlled drugs.