The Retail/Community Pharmacy is the last link in the supply chain for medicinal product from the Manufacturer to the Patient. The transport and storage of medicinal product requiring Controlled Temperature storage -label requirements “do not store above 25°C” and cold chain storage – label requirements  “store between 2°C and 8°C” are applicable to this sector.

The Retail/Community Pharmacy is regulated by the Pharmaceutical Society of Ireland (PSI) and must also comply with EU/HPRA guidelines for storage and transport of medicinal product.

PSI GUIDELINES

• PSI “Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business” Date : May 2011

EU/HPRA GUIDELINES

• EU GDP Guidelines 2013/C 343/01
• HPRA “Guide to Control and Monitoring of Storage and Transportation Temperature conditions for Medicinal Products and Active Substances”, IA-G0011-1 Date 05/10/2011

LEGISLATION

• The Pharmacy Act 2007
• Statutory Instrument No 488 of 2008, Retail Pharmacy Business Regulations

Further Reference

• Pharmaceutical Society of Ireland  www.thepsi.ie
• Irish Medecines Board www.imb.ie