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

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:

  1. Agencies
  2. Other Related Bodies
  3. Legislation
  4. Useful Links
  5. Section 15 of FOI Act
  6. 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

Legislation

Irish Medicines Board Act 1995 (as amended)

Irish Medicines Board (miscellaneous provisions) Act 2006

Poisons Act 1961

Poisons Regulations 2008

Medicinal Products (link to the following legislation on a separate page)

Medicinal Products (Prescription and Control of Supply) Regulations 2003

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008

Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009

Medicinal Products (Control of Placing on the Market) Regulations 2007

Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2009

Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) (No. 2) Regulations 2009

Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) Regulations 2010

Medicinal Products (Control of Manufacture) Regulations 2007

Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009

Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010

Medicinal Products (Control of Wholesale Distribution) Regulations 2007

Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2009

Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment) Regulations 2010

Medicinal Products (Control of Advertising) Regulations 2007

European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004

European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004

European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006

European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2009

Medicinal Devices (link to the following legislation on a separate page)

European Communities (Medical Devices) Regulations, 1994

European Communities (Active Implantable Medical Devices) Regulations, 1994

European Communities (Medical Devices) (Amendment) Regulations, 2001

European Communities (In-vitro Diagnostic Medical Devices) Regulations, 2001

European Communities (Medical Devices) (Amendment) Regulations, 2002

European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations, 2003

European Communities (Medical Devices) (Tissues of Animal Origin) Regulations, 2003

European Communities (Medical Devices) (Reclassification of hip, knee and shoulder joint replacements) (Amendment) Regulations, 2007

European Communities (Medical Devices) (Amendment) Regulations, 2009

European Communities (Active Implantable Medical Devices) (Amendment) Regulations, 2009

Cosmetics (link to the following legislation on a separate page)

European Communities (Cosmetic Products) Regulations 2004

European Communities (Cosmetic Products) (Amendment) Regulations 2005

European Communities (Cosmetic Products) (Amendment No. 2) Regulations 2006

European Communities (Cosmetic Products) (Amendment No. 3) Regulations 2006

European Communities (Cosmetic Products) (Amendment No. 4) Regulations 2006

European Communities (Cosmetic Products) (Amendment No. 5) Regulations 2007

European Communities (Cosmetic Products) (Amendment) Regulations 2008

European Communities (Cosmetic Products) (Amendment No. 2) Regulations 2008

European Communities (Cosmetic Products) (Amendment) Regulations 2009

European Communities (Cosmetic Products) (Amendment No. 2) Regulations 2009

European Communities (Cosmetic Products) (Amendment) Regulations 2010

European Communities (Cosmetic Products) (Amendment) (No. 2) Regulations 2010

European Communities (Cosmetic Products) (Amendment) (No. 3) Regulations 2010

Useful Links

Medicines Directive 2001/83/EC

Medical Devices Directive 2007/47/EC

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: Vacancy

Assistant Principals: Mary Dowling

Pharmacist: Lucia Crimin

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:

  1. Agencies and other Relevant Bodies
  2. Legislation
  3. Useful Links
  4. Section 15 of FOI Act
  5. 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:

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: Vacancy

Assistant Principals: Siobhan Kennan

Pharmacist: Lucia Crimin

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:

  1. Agencies and other Relevant Bodies
  2. Legislation
  3. Useful Links
  4. Publications
  5. Section 15 of FOI Act
  6. Contact this Office

Agencies and other Relevant Bodies

Irish Medicines Board (IMB)

Health Research Board (HRB)

National Advisory Committee on Drugs (NACD)

United Nations Office of Drugs and Crime (UNODC)

International Narcotics Control Board (INCB)

European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)

Legislation

Misuse of Drugs Act 1977, as amended and Regulations made thereunder -

www.irishstatutebook.ie/1977/en/act/pub/0012/index.html

Misuse of Drugs Act 1977

Misuse of Drugs Act 1984

Misuse of Drugs Regulations 1988

Misuse of Drugs (Amendment No. 1) Regulations 1999

Misuse of Drugs (Amendment) Regulations 2006

Misuse of Drugs (Amendment) Regulations 2007

Misuse of Drugs (Amendment) Regulations 2009

Misuse of Drugs (Amendment) (No.2) Regulations 2009

Misuse of Drugs (Amendment) Regulations 2010

Misuse of Drugs (Amendment) (No.2) Regulations 2010

Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations 1998

Useful Links

UN Convention on Narcotic Drugs 1961

UN Convention on Psychotropic Substances 1971

UN Convention on Precursor Substances 1988

Publications

National Drugs Strategy (Interim) 2009 – 2016

The Introduction of the Opioid Treatment Protocol 2010

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:

Assistant Principals: Siobhan Kennan

Pharmacist: Lucia Crimin

Tel. No. 01-6354000

Fax No. 01-6354369