EU Commission publishes important new Draft Guideline

on Good Distribution Practice of Medicinal Products for

Human Use

The Guidelines laid down in Article 84 of Directive 2001/83/EG on Good

Distribution Practice (Document 94/C 63/03) haven't been changed since their
first publication in the Official Journal of the EU in 1994. In view of the overall
progress achieved in the practice of storage and distribution and, especially
because of the new Directive 2011/62/EU on Falsified Medicines which is
intended to provide Guidelines on Good Distribution Practice, a revision of the
1994 Guidelines was necessary.

On 15 July 2011, the EU Commission published on its website a draft guideline

on Good Distribution Practice for public consultation. The deadline for
comment is ending on 31 December 2011.

The revised guidelines are definitely more extensive. A catalogue of obligations

for both medicines wholesalers and brokers is presented in 10 chapters.

Following regulations deviate from the Guideline 94/C 63/03 or have been
newly created:

Chapter 1 - Quality Management

Extensive demands for a quality management system are expressed.
Moreover, rules are presented regarding the management of outsourced
activities, risk management and review through the senior management.

Chapter 2 - Personnel
This chapter deals with the duties and responsibilities of the responsible
person and other key personnel. Besides, the chapter contains instructions
regarding training and hygiene.

Chapter 3 - Premises and Equipment

The specifications regarding the use of materials are definitely more differential
and include the handling with critical products like radioactive materials and
flammable substances. Further topics in this chapter concern: temperature and
environment control, equipment, computerised systems and
qualification/validation. The last two topics have been completely missing in
the guideline which is valid until now.

Chapter 4 - Documentation
While there were only 2 sentences in the Guideline 94/C 63/03, a whole page
of the new draft is now dedicated to documentation. Among other things, the
obligation for documents to be signed and retained for at least 5 years as well
as the necessity of a SOP system are precisely described.

Chapter 5 - Operations
In this chapter, you will find more detailed instructions on supplier and
customer qualification, storage, segregation and destruction of goods. The
FIFO principle ("first in first out") has been replaced by the "FEFO" ("first
expired first out") one which is nowadays the current storage principle anyway .

Chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products and

Medicinal Product Recalls
A paragraph was already dedicated in the Guideline from 1994 to the
distributor's obligations in case of discovery of falsified medicines. What is new
in the revised guideline is that the distributor is obliged to "inform his personnel
about the risks of falsified medicines penetrating the supply chain" which in
other words mean that the personnel must receive adequate training.

Chapter 7 - Contract Operations

This is a new topic which hadn't been dealt with in the older guideline.

Chapter 8 - Self-Inspections
The introduction of a self-inspection programme is now required. A new feature
is that audits - in the context of this programme - can also be performed by an
independent third party organisation.

Chapter 9 - Transportation
This chapter contains very detailed instructions and some improvements. For
example goods can't be stored longer than 24 hours in a distribution centre. If
there is no transportation after this time limit, the premises will be deemed to
be acting as a storage site and required to obtain a wholesalers distribution
authorisation.

Chapter 10 - Specific Provisions for Brokers

Brokers haven't been addressed yet. The new draft contains clarification
regarding the broker's activities. Brokers are not subject to premises
regulations since they don't physically handle the goods they buy and sell.
Nevertheless, they must have a quality management system and are
responsible for adequate training of their personnel - regarding the question of
falsified medicines too. This chapter also contains a list of SOPs which a
distributor has to comply with.

The requirements described in the new GDP Guideline are extensive and are
partly much more detailed than the general formulated regulations for
wholesalers which are valid for the time being. Above all they are
a consequence of the requirements of the new Directive on Falsified
Medicines.

You can access the new GDP guidelines draft here. As a comparison, you can have a
look to the Directive 94/C 63/03 - which is still valid - here.

Note:

Dr Katrin Nodop, Head of Sector Support, Sector Compliance and Inspection

Section from the European Medicine Agency will present the revision of the
GDP Guideline as well as other main elements of the new Falsified Medicine
Legislation at "The New Pharma Directive" Conference on 5-6 October 2011 in Berlin.
Meet in addition speakers e.g. from APIC, EFPIA, QP Association, IPEC at this major event.

The Directive on Falsified Medicines and its impact on the manufacture and distribution of APIs
will also be a main topic of the 14th APIC/CEFIC Conference in Munich, Germany, from
16-18 November 2011.