(AGENPARL) – LONDON mar 28 giugno 2022

The Veterinary Medicines Directorate (VMD) is responsible for inspecting and authorising veterinary wholesale dealers.

You can only wholesale an animal medicine if you have one of the following:

• a marketing authorisation

• a manufacturer’s authorisation

• a wholesale dealer’s authorisation (WDA)

And the authorisation in question relates to the product(s) you’re wholesaling. You also need a WDA if you’re a ‘virtual wholesaler’, i.e you buy and sell an animal medicine but contract out the physical handling of the medicine to another authorised wholesale dealer.

When you need a WDA

You must obtain a WDA to sell or supply medicines to anyone other than the end user.

You don’t need a wholesale dealer licence if you’re a broker. A broker is someone who has arranged for a retailer to buy animal medicines directly from a wholesale dealer at a reduced rate.

Apply for a WDA

Complete the application form for WDA (ODT, 69.5 KB) and send to the VMD.  

If you need to apply for a variation to your WDA, submit the variation application form for WDA (ODT, 70.1 KB)

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Your site will be inspected before the VMD grant your application. This inspection should take place within 90 days of your application being validated.

You can’t start wholesale dealing before you get confirmation in writing that your authorisation has been granted.

Fees

You need to pay a fee for the application for your WDA and for your initial site inspection.

You’ll also have ongoing annual and inspection fees.

The application and annual fees are not refundable or transferable.

You should qualify for a fee reduction if your annual turnover is less than £35,000 or you only deal in any of the following:

Timescales

We aim to process applications within 10 days of receipt.

Post authorisation

Once you get your authorisation, you’ll have regular inspections.

Inspections are risk based depending on your history of compliance with GDP requirements, your compliance with the Veterinary Medicines Regulations (VMR) and the type of veterinary medicines you wholesale.

You must make your site available for inspection and provide any information or samples requested.

Validity of authorisation

Your authorisation is valid indefinitely subject to satisfactory inspections. However, your WDA will be revoked if you don’t deal in veterinary medicines for 5 years.

Variation to an authorisation

You must notify the VMD before making any significant change to your premises, facilities or operations.

You must complete a variation application form for WDA (ODT, 70.1 KB) and send it to the VMD’s inspection administration team to change an existing authorisation.

Authorisation conditions

You must have a signed requisition form (signed in ink) to sell any controlled drugs listed in schedule 2 or 3 of the Misuse of Drugs Regulations 2001.

For further information see the Controlled drugs: Veterinary medicines page.

You must have a valid and suitable contract in place if you want another wholesale dealer to be responsible for the storage and distribution of your medicines. The contract must state where the division of responsibilities lies.

You must also do all of the following to meet the conditions of your authorisation:

• get animal medicines only from authorised marketing authorisation holders, manufacturers or wholesale dealers

• supply animal medicines only to people who are legally allowed to have them, for example retailers who are authorised to supply veterinary medicines to end users

• only supply animal medicines covered by your wholesale dealer’s authorisation

• list all your distribution activities in your authorisation

• store animal medicines in line with storage and transport conditions

• make sure you have proper stock rotation and carry out a detailed stock audit at least once a year

• have an emergency recall plan (a system in place that if a recall of the product is required then the company is readily able to identify and contact all their customers)

• have technically competent staff (who are trained in all of the company procedures and understand the principles of GDP)

• set up and maintain a quality system (a system detailing your quality and distribution procedures)

Site conditions

Your wholesale dealing premises must be all of the following:

WDA Qualified Person

You must choose someone to be your wholesale dealer qualified person, (WQP), and register their details with the VMD.

This is someone who is responsible for making sure you’re meeting the conditions of your authorisation. They should regularly check all areas and your quality system, and keep records of the checks they do.

This person doesn’t have to be a pharmacist, but they should know about the conditions of your authorisation and the medicines you distribute.

If they’re not a pharmacist, they should have at least a year’s experience in either of the following:

• handling, storing and distributing medicines

• supplying or obtaining medicines

They should also have at least a year’s experience in managing the wholesale distribution of medicines on a similar scale.

You don’t have to employ this person, but they must be available at all times.

Record keeping

You must keep records of all sales for at least 5 years and have them available for inspection. Your records should include all of the following:

• date and nature of the sale
• type of animal medicine
• manufacturer’s batch number
• expiry date
• quantity
• name and address of the supplier or recipient

Storage and transport conditions

You must make sure that proper storage conditions are always maintained, including during transportation, for all medicines including those that:

You should record temperatures at low and high levels – this includes in contained storage areas within warehouses, for example flammable stores.

You need to continuously record the temperature if you’re storing medicines either in small refrigerators or in warehouses.

If you’re storing medicines in large warehouses you should use temperature mapping (noting the changes in temperature in a single space caused by things like doors opening).

You should repeat temperature mapping exercises regularly and after any major change to the premises, stock layout, or heating system.

You should fit temperature alarms to large and walk-in units and those smaller units used to store products at risk from freezing. Alarms should be checked for correct functioning at the designated set temperatures at least annually.

Transport temperature: cold-chain goods

You should label the storage requirements of any medicines that need to be stored at low temperatures.

You can use insulated containers to transport small volumes of cold-chain goods. You must make sure that products which are damaged by freezing don’t come into direct contact with ice packs at sub-zero temperatures.

You can ship larger volumes of cold-chain goods in refrigerated transport. You need to use recording probes or individual temperature monitoring devices to monitor temperatures to protect products at risk from freezing.

You need to review the temperature records for each shipment and have in place a procedure for corrective action if anything goes wrong.

Temperature system checks

You need to use measuring and recording devices in critical areas, for example temperature monitoring of storage and transport facilities for cold chain goods at risk from freezing.

Your measurements should be checked against a traceable reference device (that is the temperature must be calibrated) at least once a year. Your records should show the temperature before and after.

Human medicines

If you wish to supply human medicines for veterinary use under the cascade, you must hold a WDA(H) issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA have an agreement with the VMD to issue and administer veterinary authorisations where the company undertakes both human and veterinary activities, so if your company intends to wholesale both veterinary and human products, you should apply to the MHRA. For more information, see their guidance.

Register

You can find a full list on the Register of Wholesale Dealers (PDF, 332 KB, 39 pages)

Inspections of Wholesale premises

We inspect approved wholesaler premises to ensure they comply with the VMR.

Wholesale dealer premises will generally be inspected at least every 4 years; however, this period may be extended for compliant businesses (that is few deficiencies) which conduct activities considered to be low risk. The VMD will generally give wholesalers reasonable notice that they intend carrying out a routine inspection.

Inspectors are authorised under the VMR to:

• inspect the premises, organisational arrangements and procedures used in the storage and distribution of medicinal products
• interview key personnel named on the authorisation
• take samples
• examine any documentation or records relating to the manufacture, assembly, storage and distribution of veterinary medicines

Following an inspection, the inspector will give the wholesaler a report detailing any deficiencies (also referred to as non-compliances). For major and critical deficiencies, the inspector will request details of the measures that have been, or will be, taken to correct them.

The VMD categorises deficiencies as critical, major and other (minor). The report may also include recommendations; observations made by the inspector which, whilst not a legal requirement, would be considered good practice.

Minor (Other) Deficiencies:

• minor and poses no potential risk to human or animal health, or the environment
• does not indicate a significant deviation from the requirements of the VMR, Codes of Practice or Guidance
• cannot be classified as either critical or major because there is insufficient information to classify it as such

Major Deficiencies:

• non-critical but has produced, or has the potential to produce, a possible risk to human or animal health or the environment
• a major deviation from the requirements of the VMR
• a failure to carry out satisfactory procedures to ensure that products are manufactured, stored or distributed in accordance with their specific requirements
• a combination of more than six other (minor) deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such
• other (minor) deficiencies that have been brought to the attention of the business on previous occasions but have not been resolved

Critical Deficiencies:

• deficiencies that have produced, or have the potential to produce, a significant risk to human or animal health, or the environment
• a significant deviation from the requirements of the VMR through serious negligence or intent

Inspections are scheduled at intervals based on the number and type of deficiencies noted during an inspection, as follows:

*A minor deficiency = 1 point, a Major deficiency = 7 points and a Critical deficiency =36 points

0https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file//__Register_of_GDP_Sites_280622.pdf’>https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file//__Register_of_GDP_Sites_280622.pdf

Fonte/Source: https://www.gov.uk/guidance/apply-for-a-veterinary-medicine-wholesale-dealers-authorisation-wda