Resources

Compilation of the most relevant documentation needed to get a better understanding of Good Distribution Practice (GDP). Keep abreast of the latest Regulations and Consultation releases, industry White Papers and Guidelines:

| Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) (Text with EEA relevance)

| EC No 1283/2003, Regulation put in place to better combat counterfeit and piracy - (text of the Official Journal - from the EUR-Lex Web Site)

| Forty-fourth report of the WHO Expert Committee on specifications for pharmaceutical preparations

| Directive 2001/83/ec of the Duropean Parliament and of the Council of 6 November 2001 on the Community Code relating to Medicinal products for human use - (text of the Official Journal - from the EUR-Lex Web Site)

| IMB Guide on wholesaling of medicinal products for human use in Ireland

| Guidance Note on the Notification System for Exempt Medicinal Products

| Guide to Parallel Imports - Human Medicines

| Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances

| Guidance on the recall of medicinal products for human and veterinary products

| Future Skills Requirements of the Biopharma-Pharmachem Sector (FORFAS)

| Proposal for revision of WHO good distribution practices for pharmaceutical products (including measures against penetration of counterfeits into the legitimate supply chain)

| Draft concept paper on storage conditions during transport (EMA/INS/GMP/638479/2010)

| Guideline on declaration of storage conditions: A: In the product information of medicinal products | B: for active substances

| DIRECTIVE 2011/62/EU relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products