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regulations
Good Distribution Practice (GDP) – a short guide through industry standards for the EU and the European Economic Area (EEA)
May 11, 2022
5 min read
Navigating the complexities and demands of e-commerce can be challenging, especially for online pharmaceutical businesses. We created this review to connect all the major points of the ‘GDP Guideline – Medicinal Products for Human Use’ and discuss some of the aspects of compliance, important legislation and regulations in the online pharmaceutical industry. This article is based on our research and should not be taken as an official opinion. Readers should conduct their own research and consult their own sources. Nevertheless, we hope the points we cover will help you as you consider this complex topic.
How and why does the European Medicines Agency (EMA) regulate distribution?
The pharmaceutical industry and its products are one of the most heavily regulated areas of production, which is only rational since they are fundamental parts of public healthcare. It is not out of place to underline that safety, quality, and efficacy are highly monitored aspects of a product, which calls for careful control of all stages of its lifecycle. In addition, having robust systems in place to prevent falsified medicines from entering the legal supply chain is mandatory for all licensed wholesale distributors.
Scope of influence
It is important to note that GDP only applies to medicines, as well as active and other pharmaceutical ingredients that are in their composition. Physical pharmacies are now only one channel of conducting business in order to sell medicines online and achieve a wider patient reach, it is necessary to own a digital version i.e. and online pharmacy and comply with GDP demands.
Categories that do not fall within this scope are medical devices, food supplements, biocides, or cosmetics. These groups of products are controlled to a much lesser degree, and the flow of such goods is not monitored under the GDP.
Regulations that the distributors must follow
Good manufacturing practice (GMP) and GDP are aspects of quality assurance exclusively for medicinal products (MPs) within the territories of the European Economic Area (EEA).
In a way, GMP dictates the level of quality of an MP, and GDP maintains it. Many obligations are placed upon the manufacturer, and others on the holders, importers, and distributors. GDP requirements are very similar to GMP terms for manufacturers regarding the storage of medicinal products.
Activities like procuring, holding, supplying, or exporting make up the wholesale distribution of medicinal products, apart from providing them to the public. In addition, any person acting as a wholesale distributor must have a wholesale distribution authorization.
Distribution is an integrated part of the supply-chain management of pharmaceutical products. It, therefore, has its role to play in maintaining the commodities’ attributes while they make their way to the end consumer. EU regulators enforce this with an established legal framework and their interpretations in:
- Directives 2001/83/EC (medicinal products for human use) and 2001/82/EC (veterinary use)
- Two lists of European Commission guidelines
The two lists of guidelines are divided into two categories that establish requirements for medicinal products for human use and the active substances of those respective medicinal products. Here, we will focus on the first category.
Additionally, the detailed GDP inspection and Certification processes are described here on the EMA/EU commission page.
How can online pharmacies ensure they are compliant with GDP?
Quality maintenance throughout the overall system is the responsibility of the organisation’s management and it requires leadership and skill. Formally, a specific delegate or a responsible person (RP) needs to be appointed. An RP is not any employee – they are required to meet certain qualifications: an educational background (a degree in pharmacy is preferable), training and knowledge on GDP, competence, as well as sufficient experience in the field. This person of authority ensures that the quality management system is implemented and maintained. They must take responsibility if any problems occur.
EMAs’ reworded guideline (dated 05-Nov-2013)
Under EU legislation, authorizations should apply to all distributed products. This process is done separately; companies whose products get approved are Marketing Authorisations Holders (MAHs).
As mentioned in the previous section, the responsible person has to be trained on GDP, which confirms they are competent to perform their role and can delegate tasks.
The guideline includes ten chapters addressing different distribution and storage management areas. You can view it at this address.
In the following paragraphs, we will take a look at each chapter of the GDP guideline, with the aim of giving you a general sense of what it contains.
Chapter 1: Quality Management
The first chapter explains why a wholesaler should have a quality system. The quality system makes sure that medicinal products are handled with GDP standards and delivered promptly to the proper recipients. Additional guidelines that go into more detail are found here as well, such as the management of outsourced activities and risk management.
Chapter 2: Personnel
Online pharmacies, as well as physical distributors, need competent, adequately trained personnel and a responsible person (RP) to be formally appointed and listed on the licence to accomplish their purpose.
Chapter 3: Premises and Equipment
Suitable premises, installations, computerised systems, and equipment are necessary, and certain conditions need to be maintained, such as humidity, temperature, and environmental control. Both manufacturers and wholesalers’ licences should include the storage facility itself.
Chapter 4: Documentation
Good documentation constitutes an essential part of the quality system, and authorities make sure that processes are actively being tracked and retained.
Chapter 5: Operations
Before importing, the distributor who does not own the product informs the correct Marketing Authorisations Holders and competent authority in the jurisdiction they wish to distribute. The source of the medicinal products holds a licence – either an Marketing Authorisation or a wholesale distribution authorization. Moreover, if a distributor receives medicinal products from third countries for import, these medicinal products must be obtained from a manufacturer that holds an EU GMP licence. The distributor should own a manufacturing authorization and carry out batch testing and Qualified Person release if they wish to place them on the EU market. You can also obtain medicinal products through a registered broker – which we will explain shortly.
Chapter 6: Complaints, Returns, Suspected Falsified Medicinal Products, and Medicinal Product Recalls
This is an inseparable part of all businesses including online pharmacies, and it also needs managing. Records should be kept and sometimes follow-up actions need to take place. Common examples are Corrective and Preventative Actions (CAPAs) as they are called, which are performed following a deviation.
Chapter 7: Self-Inspections
A self-inspection is another requirement needed to be performed regularly to ensure that methods in place are failsafe, or perhaps to identify faults within the organisation itself. External independent experts can be contracted to perform such inspections.
Chapter 8: Transportation
Naturally, maintenance of good storage conditions continues to the transportation phase of an MPs lifecycle. At the same time, this is the stage where most of the product damage happens due to poor control and protection, contamination, external influences, and bad handling. Audits of transporters and route validation are carried out to qualify the transporters and prevent compromising the medicinal products.
Chapter 9: Specific Provisions for Brokers
In order to be specific, a broker is not involved in the physical handling of the medicinal product but is engaged in anything concerning its sale or purchase. They are required to reside in the country where they are registered. Still, the directive requirements regarding premises, installations, and equipment do not apply to brokers since they do not procure, supply, or hold medicines.
Conclusion
To gain deeper insight into all the pieces of what comprises Good Distribution Practice, you should familiarise yourself with the directives. If you wish to obtain a GDP certificate, you should look up the list of competent authorities in Europe. You could also reach out to us, and we can connect you with an expert to help you understand what is necessary for your specific business.
References:
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0082:20090807:EN:PDF
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52013XC1123(01)&from=EN
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52015XC0321(01)
http://eudragmdp.ema.europa.eu/inspections/displayWelcome.do