With the release of new legislation around brokering, do you know what you are doing? Many are still misunderstanding the term “broker” and are brokering illegally, or without knowingly doing so.
This post from Senior Associate Bernard Lawlor may help enlighten you.
If you do any of the above, you could very well be conducting “Brokering” activities and would require a licence from the National Competent Authority, the MHRA.
Under current legislation in the EU/EEA today, anyone conducting “Brokering” activities must;
The GDP Guidelines of November 5th 2013 (2013/C 343/01) contains 11 chapters.
Chapter 10 of these GDP Guides covers specific provisions for Brokers.
It describes a Broker as 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.
Brokers are subject to a registration requirement. They must have a permanent address and contact details in the Member State where they are registered. They must notify the competent authority of any changes to those details without unnecessary delay.
By definition, brokers do not procure, supply of 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.
10.2 Quality system
The quality system of a broker should be defined in writing, approved and kept up-to-date. It should set out responsibilities, processes and risk management in relation to their activities.
The Quality system should include an emergency plan (normally in the form of a Product Recall SOP), which ensures the effective recall of medicinal products from the market, ordered by the manufacturer or the competent authorities or carried out in cooperation with the manufacturer or marketing authorisation holder (MAH) for the medicinal product concerned. The competent authorities must be informed immediately, of any suspected falsified medicines offered in the supply chain.
The competent authority in the UK is the (MHRA).
Any member of personnel involved in the brokering activities should be trained in the applicable EU and national legislation and in issues concerning falsified medicinal products.
The general provisions on documentation in Chapter 4 (commented on later) apply.
In addition, at least the following procedures and instructions, along with the corresponding records of execution, should be in place.
(i) Procedure for handling complaints
(ii) Procedure for informing competent authorities and marketing authorisation holders of suspected falsified medicinal products
(iii) Procedure for supporting recalls (emergency plan)
(iv) Procedure for ensuring that medicinal products brokered have a marketing authorisation within the EU/EEA
(v) Procedure for verifying that their supplying wholesale distributors hold a distribution authorisation, their supplying manufacturers or importers hold a manufacturing authorisation and their customers are authorised to supply medicinal products in the member state concerned.
(vi) Records should be retained and maintained either in the form of purchase/sales invoices or on computer, or in any other form for any transaction in medicinal products brokered and should contain at least the following information: date; name of the medicinal product; quantity brokered; name and address of the supplier and the customer; and batch number at least for products bearing the safety features.
Records should be made available to the competent authorities, for inspection purposes, for the period stated in national legislation but at least five years.
Records must be maintained in a secure but easily retrievable manner.
The main points from chapter 4 mentioned above, include the following;
Chapter 4 Documentation
Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products.
Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable.
Documentation should be sufficiently comprehensive with respect to the scope of the wholesale distributor’s activities and in a language understood by personnel. It should be written in clear, unambiguous language and be free from errors.
Procedures should be approved, signed and dated by the Broker.
Any correction made to the documentation should be signed and dated; the correction should permit the reading of the original information. Where appropriate, the reason for the correction should be recorded.
Records should be made at the time each operation is undertaken.
Records should be made in permanent pen.
Correction fluids should not be used.
So…. do you fall under the term “broker”?
A broker can never;
A broker must ensure;
The definition of a “Falsified Medicine” is a medicinal product with a false presentation of;
(a) It’s identity, including its packaging and labelling, its name or it’s composition as regards any of the ingredients including excipients and the strength of those ingredients; or
(b)It’s source, including its manufacturer, it’s country of manufacturing, it’s country of origin or its marketing authorisation holder: or
(c) Its history, including the records and documents relating to the distribution channels used.
The definition of “Procuring” is;
Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors.
The definition of “Supplying” is;
All activities of providing, selling, donating medicinal products to wholesalers, pharmacists or persons authorised or entitled to supply medicinal products to the public.
The definition of a “Quality system” is;
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.
If you feel you fall under the term brokering, you should contact the MHRA in the first instance, or, as ever, call us for a free five minute consultation.
For further advice or for assistance with your brokering registration application process or for compiling your quality management system, please contact us.
Welcome to a new paradigm!
17 Oct 2018
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