The Guide to Good Distribution Practice (GDP) medicinal products for human use is based on Article 84 and Article 85b, paragraph 3 of Directive 2001/83/EC of the European Parliament and of the Council of 5 November 2013.
Wholesale distribution of medicinal products is an important activity in integrated supply chain management. The drug distribution network is becoming increasingly complex and involves many parties. The GDP Guidance establishes tools to assist wholesale distributors in carrying out their activities and to prevent falsified medicinal products from entering the legitimate supply chain. Its application guarantees control over the distribution chain and therefore preserves the Quality and integrity of medicinal products.
The GDP Guidance of medicinal products for human use applies to "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned’" (Directive 2001/83/EC).
All obligations and responsibilities related to wholesale distribution activities (such as exporting, holding or supplying) also apply to these distributors. Relevant sections of these Guidelines should also be adhered to by other actors involved in the distribution of medicinal products.

Chapter 1 Quality MANAGEMENT
Wholesale distributors must maintain a Quality system setting out responsibilities, processes and risk management principles in relation to their activities (Article 80(h) of Directive 2001/83/EC).
Chapter 2 STAFF
To carry out the distribution activity, a sufficient number of competent personnel is needed to carry out all the tasks for which the wholesale distributor is responsible.
Chapter 3 PREMISES AND EQUIPMENT
Wholesale distributors must have premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products.
Chapter 4 DOCUMENTATION
Documentation comprises all written procedures, instructions, contracts, records and data in paper or in electronic form. Documentation must be available and retrievable.
Chapter 5 OPERATIONS
All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain.
Chapter 6 COMPLAINTS, RETURNS, SUSPICIOUS AND COUNTERFEIT MEDICINAL PRODUCTS AND RECALLS OF MEDICINAL PRODUCTS
All complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. Records should be made available to the competent authorities. An assessment of returned medicinal products should be performed before any approval for resale. A consistent approach by all partners in the supply chain is required in order to be successful in the fight against falsified medicinal products.
Chapter 7 OUTSOURCED ACTIVITIES
Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party.
Chapter 8 SELF-INSPECTIONS
Self-inspections should be conducted in order to monitor implementation and compliance with GDP principles and to propose necessary corrective measures.
Chapter 9 TRANSPORTATION
The supplying wholesale distributor is responsible for protecting the medicinal products from breakage, counterfeiting and theft, and to ensure that temperature conditions during transport are maintained within acceptable limits.
Chapter 10 SPECIFIC PROVISIONS FOR BROKERS
A ‘broker’ is a person involved in activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person (Art. 1, § 17a of Directive 2001/83/EC). By definition, brokers do not procure, supply or hold medicines. Therefore, requirements for premises, installations and equipment as set out in Directive 2001/83/EC do not apply. However, all other rules in Directive 2001/83/EC that apply to wholesale distributors also apply to brokers.
 
CONSEJO has experienced consultants who can suggest customized solutions suitable for your organization. We will help you prepare the necessary documentation and identify areas where you need to improve processes and implement risk management measures to ensure compliance with the requirements of the GDP Guidance.
If you need advice on implementing the requirements of the GDP  Guidance, please contact us to discuss how we can help you ensure high standards of Quality and safety in the distribution of medicinal products for human use.

GDP – Good Distribution Practice of medicinal products for human use