Good Distribution Practice: Frequently asked questions

The frequently asked questions section contains previous questions discussed at symposia, GMP/GDP Consultative Committee meetings and others received by the GDP Inspectorate.

Raised hand

Frequently asked questions relating to wholesale dealing
1. Can a registered pharmacy trade stock with other registered pharmacies without the need for a wholesale dealers authorisation?
2. I want to export medicinal products to countries outside of Europe, what authorisations do I need?
3. What documentation do I need to obtain from a customer to confirm their bona fides?
4. I hold a wholesale dealers authorisation.  Which sub-contractor sites do I need to list on my authorisation?
5. I have a UK office for the administration of wholesale dealing undertaken in other EU member states. My overseas sites all hold wholesale dealers authorisations issued by the relevant EU competent authorities and are separate businesses to my UK office. Do I need a UK wholesale dealers authorisation?
6. Does a company that only holds parallel import product licences need a wholesale dealers authorisation?
7. I own a number of retail pharmacies and would like to know if I need a wholesale dealers authorisation to procure centrally and to supply my own branches.
8. My company provides storage and distribution services for clients. I have been advised that where a client sub-contracts their storage and distribution activities to my company, provided that they are the product licence holder, they do not need a wholesale dealers authorisation. Is this correct?
9. What is the MHRA’s view about samples of medicinal products being issued to a sales representative?
10. Where does the MHRA stand on the use of Mean Kinetic Temperature calculation? In what context may it be used as part of a risk assessment when a deviation / temperature excursion occurs?


1. Can a registered pharmacy trade stock with other registered pharmacies without the need for a wholesale dealers authorisation?
With effect from July 2012 Section 10(7) of the Medicines Act 1968 will be repealed. Section 10(7) currently provides an exemption in UK law from the requirement for a pharmacist to hold a Wholesale Dealer’s Licence if they trade in medicines in certain circumstances. Its repeal is necessary in order to comply with EU legislation, in particular, Articles 77(1) and 77(2) of Directive 2001/83/EC which require anyone undertaking wholesale dealing activities to hold a Wholesale Dealer’s Licence.

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2. I want to export medicinal products to countries outside of Europe, what authorisations do I need?
To export medicinal products you must hold a Wholesale Dealers Authorisation and comply with the Guidelines on Good Distribution Practice.

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3. What documentation do I need to obtain from a customer to confirm their bona fides?
The MHRA does not prescribe the documentation required to confirm that a customer is authorised to receive medicinal products from a wholesale dealer, as the documentation available will vary from case to case. Examples include, but are not limited to, public registers of wholesale dealers or pharmacies, copies of wholesale dealer’s licences, doctor’s or dentist’s licences.

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4. I hold a wholesale dealers authorisation.  Which sub-contractor sites do I need to list on my licence?
Any sites or businesses that are used for the sale, storage or distribution of medicinal products. The responsibilities for each sub-contracted site should be clearly defined in a technical agreement, particularly the areas covered by the individual Responsible Person for the contract giver and contract receiver. The MHRA does not recommend that the same Responsible Person is used by both parties to the technical agreement as this may lead to a conflict of interest.

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5. I have a UK office for the administration of wholesale dealing undertaken in other EU member states. My overseas sites all hold wholesale dealers authorisations issued by the relevant EU competent authorities and are separate businesses to my UK office. Do I need a UK wholesale dealers authorisation?
Wholesale dealing is defined in Regulation 18(7) of The Human Medicines Regulations 2012 [SI 2012/1916] as:

"selling or supplying it; or procuring or holding it or exporting it to another EEA State for the purposes of sale or supply, to a person who receives it for a purpose …. " of  " selling or supplying the product; or administering it or causing it to be administered to one or more human beings".

If a UK-based business undertakes any activities relating to the sale, supply, procurement, storage or distribution of medicinal products within the EEA, and is not the manufacturer or marketing authorisation holder for that medicinal product, then they will need to hold a wholesale dealers authorisation. It is not necessary to be undertaking all the activities defined as wholesale dealing any one activity is sufficient to require an authorisation.

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6. Does a company that only holds parallel import product licences need a wholesale dealers authorisation?
If the company is not conducting any wholesaler dealing activity in relation to medicinal products for human use, it will not require a wholesale dealer's licence. If the company is not procuring, holding or supplying a medicinal product for human use it will not require a wholesale dealer's licence, unless there are assembly activities being undertaken.

If the holder of the product licence for parallel import (PLPI) directly distributes the medicinal product(s) for which they hold authorisation(s) from the site of assembly, no wholesale dealer's licence is required.

Where a parallel imported product is subject to assembly (for example re-labelling and re-packaging) after import, a manufacturer’s authorisation for assembly will be required. This can be performed under contract with an appropriately authorised site (named on the parallel import licence) should the PLPI holder not wish to obtain a manufacturer’s authorisation. For the exemption from the need to hold a wholesale dealer's licence to apply, the re-packaged product must be distributed from a site identified on the PLPI. If the product is then transferred to another site not identified on the PLPI, a wholesale dealer's licence will be required for the receiving site.

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7. I own a number of retail pharmacies and would like to know if I need a wholesale dealers authorisation to procure centrally and to supply my own branches.
Self distribution within the same legal entity is not wholesale distribution, therefore a WDA is not required for this activity. Further advice should be obtained from either the General Pharmaceutical Council or  the Pharmaceutical Society of Northern Ireland as appropriate for their requirements for the registration of non pharmacy premises within their territory.

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8. My company provides storage and distribution services for clients. I have been advised that where a client sub-contracts their storage and distribution activities to my company, provided that they are the product licence holder, they do not need a wholesale dealers authorisation. Is this correct?
As a result of  Regulation 19(1) of The Human Medicines Regulations 2012 [SI 2012/1916] a product authorisation holder is exempt from the need to hold a Wholesale Dealer’s Licence to distribute their product by way of wholesale dealing providing that the storage and distribution of medicinal products covered by that authorisation is undertaken from the site of manufacture or assembly named on the manufacturers or assemblers manufacturer's licence. Where a medicinal product is moved to another site for storage or distribution then this exemption is lost, and the authorisation holder of the product that is conducting a wholesale dealing activity in distributing their medicines will require a Wholesale Dealer's Licence.

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9. What is the MHRA’s view about samples of medicinal products being issued to a sales representative?

Under the legislation on advertising medicines, companies may only provide free samples to persons qualified to prescribe the medicine. Samples may only be supplied in response to a signed and dated request from the prescriber and must be appropriately labelled and accompanied by a copy of the Summary of Product Characteristics (SPC). The company must have adequate procedures for control and accountability for all samples. See section 6.12 of the MHRA Blue GuidePDF file (opens in new window) (206Kb) for details of the legal requirements.

The MHRA is aware that in some cases sales representatives receive samples to fill prescriber requests and that the medicinal products are delivered to them by colleagues or by couriers. Either way, the storage and delivery arrangements for these medicinal products must be validated to ensure the medicinal product will be transported expeditiously under controlled Good Distribution Practice (GDP) conditions and in accordance with labelled storage requirements at all times. It is highly unlikely that samples requiring refrigeration will meet these requirements. With regards to storage, it is not acceptable for samples to be stored in the representative’s home, on unlicensed premises, which are not GDP compliant, lacking appropriate storage facilities, security and controls to maintain the quality of the medicines and provide an audit trail.

Likewise distribution of samples involving delivery in a representative’s vehicle that has no provision for maintaining correct storage conditions is also unacceptable. Temperatures in a car boot in high summer could reach 50 degrees Celsius or go below 0 in winter. The practice of providing sales representatives with samples of medicinal products which they retain for onward distribution is therefore unlikely to be acceptable due to the storage and transport difficulties outlined above. The only reason for which sales representatives may hold samples on a long-term basis is for the purpose of product identification. In this regard procedures must be in place to ensure accountability for any such stock and to ensure no packs are provided to healthcare professionals.

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10. Where does the MHRA stand on the use of Mean Kinetic Temperature calculation? In what context may it be used as part of a risk assessment when a deviation / temperature excursion occurs?
Mean Kinetic Temperature (MKT) should not be used to compensate for poor temperature control of storage (or transportation) facilities. It may be applied in situations where control is good but where occasional excursions may be encountered. (J. Taylor. ‘Recommendations on the Control and Monitoring of Storage and Transportation Temperatures of Medicinal Products’ The Pharmaceutical Journal (vol 267) July 2001).

It is not possible to obtain a meaningful MKT value from daily readings of simple max / min thermometers as temperature fluctuation is not a linear function. It is noted that some data loggers and building management systems are capable of recording multiple temperature readings over a time period and some offer the function of calculating the MKT over a given time period.

Temperature deviations usually fall into one of two categories: A ‘spike’ deviation where local conditions vary in such a way as the temperature suddenly deviates from and quickly recovers to within the required range and a ‘plateau’ deviation where the temperature lays outside of the range for an extended time period prior to eventual recovery. These two deviations can have differing effect of the product.

It is unlikely that the wholesale authorisation holder will have sufficient data in his possession to assess the potential impact on a specific product of these deviations. In the event of a temperature deviation, the wholesale authorisation holder should seek advice from the marketing authorisation holder of the medicinal item in question.

If the wholesale authorisation holder is able to provide the marketing authorisation holder with details of MKT that the product has been subjected to whilst in his care as well as the times and extent of the temperature deviation, this may assist the marketing authorisation holder in formulating his advice to the wholesale authorisation holder.


Common deficiencies

Review of deficiency data from January - December 2011
Data in this presentation is a summary of all the data reviewed in 2011. During this period 275 GDP inspections were carried out of which 61 related to new applications and 214 related to existing licences.

Review of GDP deficienciesPDF file (opens in new window) (69Kb)

Review of deficiency data June 2011
The sample for review was selected from GDP inspections carried out between 1 and 30 June 2011. During this period 51 GDP inspections were carried out representing 49 individual companies of which 12 were new WDA applications.

There were 32 blood bank establishments inspected by GDP Inspectorate that are not included due to being dissimilar to other wholesalers in respect to comparing deficiencies for review. Deficiencies included in the review refer to non-compliance areas rather than single deficiency clauses as stated in post-inspection letters.

Review of GDP deficiencies Powerpoint file (opens in new window) (3665Kb)

Review of deficiency data March 2011
The sample for review was selected from GDP inspections carried out between 2nd and 30th March 2011. During this period 123 GDP inspections were carried out representing 90 individual companies of which 18 were new WDA applications. Two unannounced inspections were carried out in order to investigate specific enquiries and are not included in the sample. Where inspections were carried out on multiple sites within the same company only the first inspection is included in the sample in order to not over-represent deficiencies that are company-specific.

In order to maintain the proportion of new applications represented 10 new application sites and 40 established sites were included in the sample. Of two combined sites inspected one was included in the sample. Deficiencies included in the review refer to non-compliance areas rather than single deficiency clauses as stated in post-inspection letters.

Review of GDP deficiencies Powerpoint file (opens in new window) (2025Kb)

Review of deficiency data October 2010
The process for review of GDP deficiencies has been modified in order to keep pace with the rapidly changing supply chain environment and improve customer focus. In future a sample of inspections will be reviewed and specific detail added as appropriate. It is hoped that this will help wholesalers better understand the requirements of GDP and improve their quality systems accordingly.

The sample in this review comprised of 50 representative GDP inspections of those carried out during the period 1 October 2010 to 31 October 2010. Of these 11 were new applications and the remaining 39 were routine or carried out in response to variations submitted.

Review of GDP Deficiencies Powerpoint file (opens in new window) (1797Kb)

Some common inspection findings and current areas of concern that have been identified during recent inspections have been included in the following examples.
The top ten deficiencies and counterfeit awarenessPDF file (opens in new window) (216Kb)

Review of deficiency data from July 2009 to June 2010
The attached presentation includes conformation of the top five deficiencies and a comparison of deficiency trends.

GDP Inspectorate Ranking of DeficienciesPDF file (opens in new window) (90Kb)

Deficiency classification
The GMP/GDP Inspectorate has collated data from post inspection letters in order to provide information on the number of critical and major deficiencies reported and identify the top five serious issues.

For April 2008 - March 2009
Data reviewed to date indicates the top five deficiencies as:

  • lack of, or inadequate written procedures - 30
  • general storage - temperature control and monitoring - 24
  • unauthorised activity - 19
  • quality system and duties of the Responsible Person - 18
  • cold storage - temperature control and monitoring - 13.

For April 2009 - June 2009
Data reviewed to date indicates the top five deficiencies as:

  • lack of, or inadequate written procedures - 13
  • general storage - temperature control and monitoring - 11
  • cold chain transportation - 9
  • unauthorised activity - 8
  • cold storage - temperature control and monitoring - 8.

Review of deficiency data from April 2009 to October 2009
The attached review confirms the main deficiency categories as:

  • temperature conditions
  • quality management system
  • documentation
  • premises and equipment
  • orders and supply
  • products.

The data includes confirmation of the number of deficiencies for each category and examples of deficiencies in meeting GDP requirements.

GDP Inspectorate ranking of deficienciesPDF file (opens in new window) (313Kb)


Page last modified: 24 December 2013