- Pharmaceutical Consultancy
- References Medical
References
Pharmaceutical
- EudraLex volume 4 – Good Manufacturing Practice (GMP Guidelines) https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en#introduction
- COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015, supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.
- EU Directive 2001/83/EC amended by FMD directive 2011/62 /EU and supplemented by Commission directive (EU) 2017/1572
- EU Directive 2003/94/EC – Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use – Article 7
- EU Directive 2001/82/EC – Community Code relating Community Code relating to Medicinal Products for Human Use -Title IV – Manufacture and Importation – Articles 40-53
- HPRA Guide to Good Distribution of Medicinal Products for Human Use
- SI 539 of ‘Medicinal Products (Control of Manufacture) Regulations- SI amendments
- I. No. 36/2019 – Medicinal Products (Safety Features On Packaging) Regulations 2019
- I. No. 163/2013 – Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013.
- I. No. 273/2012 – Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012.
- I. No. 288/2010 – Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010.
- I. No. 4/2009 – Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009
- I. No. 219/2019 – Medicinal Products (Control of Manufacture) (Amendment) Regulations 2019
Medical Devices
- Regulation 2017/745 on Medical Devices (MDR),
- Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR)
- Guide for Distributors of Medical Devices IA-G0004-2 19 DECEMBER 2020
- ISO 13485 (QMS MD)
- MD RA ISO14971 (Risk assessment)
- ISO 62366 (Usability)
Guidelines
- EU Guidelines on Good Distribution Practice of medicinal products for Human Use
- HPRA Guide to Good Distribution of Medicinal Products for Human Used (as mended)
- MHRA Rules and Guidance for Pharmaceutical Manufactured and Distributors (as amended)
