EUROPEAN

COMMISSION

Brussels, XXX
[…](2013) XXX draft

Guidelines

of XXX

on Good Distribution Practice of Medicinal Products for Human Use

(Text with EEA relevance)

EN EN
 Guidelines

of XXX

on Good Distribution Practice of Medicinal Products for Human Use

(Text with EEA relevance)

 INTRODUCTION

These Guidelines are based on Articles 84 and 85(b) (3) of Directive 2001/83/EC1.
The Commission has published EU Guidelines on good distribution practice (GDP)
in 19942. Revised guidelines were published in March 20133 in order to take into
account recent advances in practices for appropriate storage and distribution of
medicinal products in the European Union, as well as new requirements introduced
by Directive 2011/62/EU4.
This version corrects factual mistakes identified in subchapters 5.5 and 6.3 of the
revised guidelines. It also gives more explanations on the rationale for the revision as
well as a date of coming into operation.
It replaces the guidelines on GDP published in March 2013.
The wholesale distribution of medicinal products is an important activity in
integrated supply chain management. Today’s distribution network for medicinal
products is increasingly complex and involves many players. These guidelines lay
down appropriate tools to assist wholesale distributors in conducting their activities
and to prevent falsified medicines from entering the legal supply chain. Compliance
with these guidelines will ensure control of the distribution chain and consequently
maintain the quality and the integrity of medicinal products.
According to Article 1(17) of Directive 2001/83/EC, wholesale distribution of
medicinal products is ‘all activities consisting of procuring, holding, supplying or
exporting medicinal products, apart from supplying medicinal products to the public.
Such activities are carried out with manufacturers or their depositories, importers,
other wholesale distributors or with pharmacists and persons authorized or entitled to
supply medicinal products to the public in the Member State concerned.
Any person acting as a wholesale distributor has to hold a wholesale distribution
authorisation. Article 80(g) of Directive 2001/83/EC provides that distributors
must comply with the principles of and guidelines for GDP.
Possession of a manufacturing authorisation includes authorisation to distribute the
medicinal products covered by the authorisation. Manufacturers performing any
distribution activities with their own products must therefore comply with GDP.
The definition of wholesale distribution does not depend on whether that
distributor is established or operating in specific customs areas, such as in free zones
or in free warehouses. All obligations related to wholesale distribution activities
(such as exporting, holding or supplying) also apply to these distributors. Relevant
sections of these guidelines should also be adhered to by other actors involved in the
distribution of medicinal products.

1
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67.
2
Guidelines on Good Distribution Practice of Medicinal Products for Human Use, OJ C 63, 1.3.1994, p.
4.
3
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use, OJ C
68, 8.3.2013, p. 1.
4
Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC
as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L
174, 1.7.2011, p.74
Other actors such as brokers may also play a role in the distribution channel for
medicinal products. According to Article 85b of Directive 2001/83/EC, persons
brokering medicinal products must be subject to certain provisions applicable to
wholesale distributors, as well as specific provisions on brokering.
1. CHAPTER 1 – QUALITY MANAGEMENT
1.1. Principle
Wholesale distributors must maintain a quality system setting out responsibilities,
processes and risk management principles in relation to their activities5. All
distribution activities should be clearly defined and systematically reviewed. All
critical steps of distribution processes and significant changes should be justified and
where relevant validated. The quality system is the responsibility of the
organisation’s management and requires their leadership and active participation and
should be supported by staff commitment.
1.2. Quality System
The system for managing quality should encompass the organisational structure,
procedures, processes and resources, as well as activities necessary to ensure
confidence that the product delivered maintains its quality and integrity and remains
within the legal supply chain during storage and/or transportation.
The quality system should be fully documented and its effectiveness monitored. All
quality-system-related activities should be defined and documented. A quality
manual or equivalent documentation approach should be established.
A responsible person should be appointed by the management, who should have
clearly specified authority and responsibility for ensuring that a quality system is
implemented and maintained.
The management of the distributor should ensure that all parts of the quality system
are adequately resourced with competent personnel, and suitable and sufficient
premises, equipment and facilities.
The size, structure and complexity of distributor’s activities should be taken into
consideration when developing or modifying the quality system.
A change control system should be in place. This system should incorporate quality
risk management principles, and be proportionate and effective.
The quality system should ensure that:
i) medicinal products are procured, held, supplied or exported in a way that is
compliant with the requirements of GDP;
ii) management responsibilities are clearly specified;
iii) products are delivered to the right recipients within a satisfactory time period;
iv) records are made contemporaneously;
v) deviations from established procedures are documented and investigated;
vi) appropriate corrective and preventive actions (commonly known as CAPA)
are taken to correct deviations and prevent them in line with the principles of quality
risk management.

5
Article 80(h) of Directive 2001/83/EC.
1.3. Management of Outsourced Activities
The quality system should extend to the control and review of any outsourced
activities related to the procurement, holding, supply or export of medicinal products.
These processes should incorporate quality risk management and include:
i) assessing the suitability and competence of the contract acceptor to carry out the
activity and checking authorisation status, if required;
ii) defining the responsibilities and communication processes for the quality-related
activities of the parties involved;
iii) monitoring and review of the performance of the contract acceptor, and the
identification and implementation of any required improvements on a regular basis.
1.4. Management Review and Monitoring
The management should have a formal process for reviewing the quality system on a
periodic basis. The review should include:
i) measurement of the achievement of quality system objectives;
ii) assessment of performance indicators that can be used to monitor the effectiveness
of processes within the quality system, such as complaints, deviations, CAPA,
changes to processes; feedback on outsourced activities; self-assessment processes
including risk assessments and audits; and external assessments such as inspections,
findings and customer audits;
iii) emerging regulations, guidance and quality issues that can impact the quality
management system;
iv) innovations that might enhance the quality system;
v) changes in business environment and objectives.
The outcome of each management review of the quality system should be
documented in a timely manner and effectively communicated internally.
1.5. Quality Risk Management
Quality risk management is a systematic process for the assessment, control,
communication and review of risks to the quality of medicinal products. It can be
applied both proactively and retrospectively.
Quality risk management should ensure that the evaluation of the risk to quality is
based on scientific knowledge, experience with the process and ultimately links to
the protection of the patient. The level of effort, formality and documentation of the
process should be commensurate with the level of risk. Examples of the processes
and applications of quality risk management can be found in guideline Q9 of the
International Conference on Harmonisation (‘ICH’).
2. CHAPTER 2 – PERSONNEL
2.1. Principle
The correct distribution of medicinal products relies upon people. For this reason,
there must be sufficient competent personnel to carry out all the tasks for which the
wholesale distributor is responsible. Individual responsibilities should be clearly
understood by the staff and be recorded.
2.2. Responsible Person
The wholesale distributor must designate a person as Responsible Person. The
Responsible Person should meet the qualifications and all conditions provided for by
the legislation of the Member State concerned6. A degree in pharmacy is desirable.
The Responsible Person should have appropriate competence and experience as well
as knowledge of and training in GDP.
The Responsible Person should fulfil their responsibilities personally and should be
continuously contactable. The Responsible Person may delegate duties but not
responsibilities.
The written job description of the Responsible Person should define their authority to
take decisions with regard to their responsibilities. The wholesale distributor should
give the Responsible Person the defined authority, resources and responsibility
needed to fulfil their duties.
The Responsible Person should carry out their duties in such a way as to ensure that
the wholesale distributor can demonstrate GDP compliance and that public service
obligations are met.
The responsibilities of the Responsible Person include:
i) ensuring that a quality management system is implemented and maintained;
ii) focusing on the management of authorised activities and the accuracy and quality
of records;
iii) ensuring that initial and continuous training programmes are implemented and
maintained;
iv) coordinating and promptly performing any recall operations for medicinal
products;
v) ensuring that relevant customer complaints are dealt with effectively;
vi) ensuring that suppliers and customers are approved;
vii) approving any subcontracted activities which may impact on GDP;
viii) ensuring that self-inspections are performed at appropriate regular intervals
following a prearranged programme and necessary corrective measures are put in
place;
ix) keeping appropriate records of any delegated duties;
x) deciding on the final disposition of returned, rejected, recalled or falsified
products;

6
Article 79(b) of Directive 2001/83/EC.
 xi) approving any returns to saleable stock;
xii) ensuring that any additional requirements imposed on certain products by
national law are adhered to7.
2.3. Other Personnel
There should be an adequate number of competent personnel involved in all stages of
the wholesale distribution activities of medicinal products. The number of personnel
required will depend on the volume and scope of activities.
The organisational structure of the wholesale distributor should be set out in an
organisation chart. The role, responsibilities, and interrelationships of all personnel
should be clearly indicated.
The role and responsibilities of employees working in key positions should be set out
in written job descriptions, along with any arrangements for deputising.
2.4. Training
All personnel involved in wholesale distribution activities should be trained on the
requirements of GDP. They should have the appropriate competence and experience
prior to commencing their tasks.
Personnel should receive initial and continuing training relevant to their role, based
on written procedures and in accordance with a written training programme. The
Responsible Person should also maintain their competence in GDP through regular
training.
In addition, training should include aspects of product identification and avoidance
of falsified medicines entering the supply chain.
Personnel dealing with any products which require more stringent handling
conditions should receive specific training. Examples of such products include
hazardous products, radioactive materials, products presenting special risks of abuse
(including narcotic and psychotropic substances), and temperature-sensitive
products.
A record of all training should be kept, and the effectiveness of training should be
periodically assessed and documented.
2.5. Hygiene
Appropriate procedures relating to personnel hygiene, relevant to the activities being
carried out, should be established and observed. Such procedures should cover
health, hygiene and clothing.

7
Article 83 of Directive 2001/83/EC.
3. CHAPTER 3 – PREMISES AND EQUIPMENT
3.1. Principle
Wholesale distributors must have suitable and adequate premises, installations and
equipment8, so as to ensure proper storage and distribution of medicinal products.
In particular, the premises should be clean, dry and maintained within acceptable
temperature limits.
3.2. Premises
The premises should be designed or adapted to ensure that the required storage
conditions are maintained. They should be suitably secure, structurally sound and of
sufficient capacity to allow safe storage and handling of the medicinal products.
Storage areas should be provided with adequate lighting to enable all operations to be
carried out accurately and safely.
Where premises are not directly operated by the wholesale distributor, a contract
should be in place. The contracted premises should be covered by a separate
wholesale distribution authorisation.
Medicinal products should be stored in segregated areas which are clearly marked
and have access restricted to authorised personnel. Any system replacing physical
segregation, such as electronic segregation based on a computerised system, should
provide equivalent security and should be validated.
Products pending a decision as to their disposition or products that have been
removed from saleable stock should be segregated either physically or through an
equivalent electronic system. This includes, for example, any product suspected of
falsification and returned products. Medicinal products received from a third country
but not intended for the Union market should also be physically segregated. Any
falsified medicinal products, expired products, recalled products and rejected
products found in the supply chain should be immediately physically segregated and
stored in a dedicated area away from all other medicinal products. The appropriate
degree of security should be applied in these areas to ensure that such items remain
separate from saleable stock. These areas should be clearly identified.
Special attention should be paid to the storage of products with specific handling
instructions as specified in national law. Special storage conditions (and special
authorisations) may be required for such products (e.g. narcotics and psychotropic
substances).
Radioactive materials and other hazardous products, as well as products presenting
special safety risks of fire or explosion (e.g. medicinal gases, combustibles,
flammable liquids and solids), should be stored in one or more dedicated areas
subject to local legislation and appropriate safety and security measures.
Receiving and dispatch bays should protect products from prevailing weather
conditions. There should be adequate separation between the receipt and dispatch
and storage areas. Procedures should be in place to maintain control of
inbound/outbound goods. Reception areas where deliveries are examined following
receipt should be designated and suitably equipped.

8
Article 79(a) of Directive 2001/83/EC.
 Unauthorised access to all areas of the authorised premises should be prevented.
Prevention measures would usually include a monitored intruder alarm system and
appropriate access control. Visitors should be accompanied.
Premises and storage facilities should be clean and free from litter and dust. Cleaning
programmes, instructions and records should be in place. Appropriate cleaning
equipment and cleaning agents should be chosen and used so as not to present a
source of contamination.
Premises should be designed and equipped so as to afford protection against the entry
of insects, rodents or other animals. A preventive pest control programme should be
in place.
Rest, wash and refreshment rooms for employees should be adequately separated
from the storage areas. The presence of food, drink, smoking material or medicinal
products for personal use should be prohibited in the storage areas.
3.2.1. Temperature and Environment Control
Suitable equipment and procedures should be in place to check the environment
where medicinal products are stored. Environmental factors to be considered include
temperature, light, humidity and cleanliness of the premises.
An initial temperature mapping exercise should be carried out on the storage area
before use, under representative conditions. Temperature monitoring equipment
should be located according to the results of the mapping exercise, ensuring that
monitoring devices are positioned in the areas that experience the extremes of
fluctuations. The mapping exercise should be repeated according to the results of a
risk assessment exercise or whenever significant modifications are made to the
facility or the temperature controlling equipment. For small premises of a few square
meters which are at room temperature, an assessment of potential risks (e.g. heaters)
should be conducted and temperature monitors placed accordingly.
3.3. Equipment
All equipment impacting on storage and distribution of medicinal products should be
designed, located and maintained to a standard which suits its intended purpose.
Planned maintenance should be in place for key equipment vital to the functionality
of the operation.
Equipment used to control or to monitor the environment where the medicinal
products are stored should be calibrated at defined intervals based on a risk and
reliability assessment.
Calibration of equipment should be traceable to a national or international
measurement standard. Appropriate alarm systems should be in place to provide
alerts when there are excursions from pre-defined storage conditions. Alarm levels
should be appropriately set and alarms should be regularly tested to ensure adequate
functionality.
Equipment repair, maintenance and calibration operations should be carried out in
such a way that the integrity of the medicinal products is not compromised.
Adequate records of repair, maintenance and calibration activities for key equipment
should be made and the results should be retained. Key equipment would include for
example cold stores, monitored intruder alarm and access control systems,
refrigerators, thermo hygrometers, or other temperature and humidity recording
 devices, air handling units and any equipment used in conjunction with the onward
supply chain.
3.3.1. Computerised Systems
Before a computerised system is brought into use, it should be demonstrated, through
appropriate validation or verification studies, that the system is capable of achieving
the desired results accurately, consistently and reproducibly.
A written, detailed description of the system should be available (including diagrams
where appropriate). This should be kept up-to-date. The document should describe
principles, objectives, security measures, system scope and main features, how the
computerised system is used and the way it interacts with other systems.
Data should only be entered into the computerised system or amended by persons
authorised to do so.
Data should be secured by physical or electronic means and protected against
accidental or un-authorised modifications. Stored data should be checked
periodically for accessibility. Data should be protected by backing up at regular
intervals. Back up data should be retained for the period stated in national legislation
but at least five years at a separate and secure location.
Procedures to be followed if the system fails or breaks down should be defined. This
should include systems for the restoration of data.
3.3.2. Qualification and Validation
Wholesale distributors should identify what key equipment qualification and/or key
process validation is necessary to ensure correct installation and operation. The scope
and extent of such qualification and/or validation activities (such as storage, pick and
pack processes) should be determined using a documented risk assessment approach.
Equipment and processes should be respectively qualified and/or validated before
commencing use and after any significant changes e.g. repair or maintenance.
Validation and qualification reports should be prepared summarising the results
obtained and commenting on any observed deviations. Deviations from established
procedures should be documented and further actions decided to correct deviations
and avoid their re-occurrence (corrective and preventive actions). The principles of
CAPA should be applied where necessary. Evidence of satisfactory validation and
acceptance of a process or piece of equipment should be produced and approved by
appropriate personnel.
4. CHAPTER 4 – DOCUMENTATION
4.1. Principle
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.
4.2. General
Documentation comprises all written procedures, instructions, contracts, records and
data, in paper or in electronic form. Documentation should be readily
available/retrievable.
With regard to the processing of personal data of employees, complainants or any
other natural person, Directive 95/46/EC9 on the protection of individuals applies to
the processing of personal data and to the free movement of such data.
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.
Procedure should be approved signed and dated by the responsible person.
Documentation should be approved, signed and dated by appropriate authorised
persons, as required. It should not be hand-written; although, where it is necessary,
sufficient space should be provided for such entries.
Any alteration made in the documentation should be signed and dated; the alteration
should permit the reading of the original information. Where appropriate, the reason
for the alteration should be recorded.
Documents should be retained for the period stated in national legislation but at least
five years. Personal data should be deleted or anonymised as soon as their storage is
no longer than necessary for the purpose of distribution activities.
Each employee should have ready access to all necessary documentation for the tasks
executed.
Attention should be paid to using valid and approved procedures. Documents should
have unambiguous content; title, nature and purpose should be clearly stated.
Documents should be reviewed regularly and kept up-to-date. Version control should
be applied to procedures. After revision of a document a system should exist to
prevent inadvertent use of the superseded version. Superseded or obsolete procedures
should be removed from workstations and archived.
Records must be kept either in the form of purchase/sales invoices, delivery slips, or
on computer or any other form, for any transaction in medicinal products received,
supplied or brokered.
Records must include at least the following information: date; name of the medicinal
product; quantity received, supplied or brokered; name and address of the supplier,
customer, broker or consignee, as appropriate; and batch number at least for
medicinal product bearing the safety features10.
Records should be made at the time each operation is undertaken.
9
OJ L 281 , 23.11.1995, p.31
10
Article 80(e) and 82 of Directive 2001/83/EC.
5. CHAPTER 5 – OPERATIONS
5.1. Principle
All actions taken by wholesale distributors should ensure that the identity of the
medicinal product is not lost and that the wholesale distribution of medicinal
products is performed according to the information on the outer packaging. The
wholesale distributor should use all means available to minimise the risk of falsified
medicinal products entering the legal supply chain.
All medicinal products distributed in the EU by a wholesale distributor must be
covered by a marketing authorisation granted by the EU or by a Member State11.
Any distributor, other than the marketing authorisation holder, who imports a
medicinal product from another Member State must notify the marketing
authorisation holder and the competent authority in the Member State to which the
medicinal product will be imported of their intention to import that product12. All
key operations described below should be fully described in the quality system in
appropriate documentation.
5.2. Qualification of Suppliers
Wholesale distributors must obtain their supplies of medicinal products only from
persons who are themselves in possession of a wholesale distribution authorisation,
or who are in possession of a manufacturing authorisation which covers the product
in question13.
Wholesale distributors receiving medicinal products from third countries for the
purpose of importation, i.e. for the purpose of placing these products on the EU
market, must hold a manufacturing authorisation14.
Where medicinal products are obtained from another wholesale distributor the
receiving wholesale distributor must verify that the supplier complies with the
principles and guidelines of good distribution practices and that they hold an
authorisation for example by using the Union database. If the medicinal product is
obtained through brokering, the wholesale distributor must verify that the broker is
registered and complies with the requirements in Chapter 1015.
Appropriate qualification and approval of suppliers should be performed prior to any
procurement of medicinal products. This should be controlled by a procedure and the
results documented and periodically rechecked.
When entering into a new contract with new suppliers the wholesale distributor
should carry out ‘due diligence’ checks in order to assess the suitability, competence
and reliability of the other party. Attention should be paid to:
i) the reputation or reliability of the supplier,
ii) offers of medicinal products more likely to be falsified,
iii) large offers of medicinal products which are generally only available in limited
quantities, and
11
Article 76(1) and (2) of Directive 2001/83/EC.
12
Article 76(3) of Directive 2001/83/EC
13
Article 80(b) of Directive 2001/83/EC.
14
Article 40(3) of Directive 2001/83/EC.
15
Article 80, fourth paragraph of Directive 2001/83/EC.
 iv) out-of-range prices.
5.3. Qualification of Customers
Wholesale distributors must ensure they supply medicinal products only to persons
who are themselves in possession of a wholesale distribution authorisation or who
are authorised or entitled to supply medicinal products to the public.
Checks and periodic re-checks may include: requesting copies of customer’s
authorisations according to national law, verifying status on an authority website,
requesting evidence of qualifications or entitlement according to national legislation.
Wholesale distributors should monitor their transactions and investigate any
irregularity in the sales patterns of narcotics, psychotropic substances or other
dangerous substances. Unusual sales patterns that may constitute diversion or misuse
of medicinal product should be investigated and reported to competent authorities
where necessary. Steps should be taken to ensure fulfilment of any public service
obligation imposed upon them.
5.4. Receipt of Medicinal Products
The purpose of the receiving function is to ensure that the arriving consignment is
correct, that the medicinal products originate from approved suppliers and that they
have not been visibly damaged during transport.
Medicinal products requiring special storage or security measures should be
prioritised and once appropriate checks have been conducted they should be
immediately transferred to appropriate storage facilities.
Batches of medicinal products intended for the EU and EEA countries should not be
transferred to saleable stock before assurance has been obtained in accordance with
written procedures, that they are authorised for sale. For batches coming from
another Member State, prior to their transfer to saleable stock, the control report
referred to in Article 51(1) of Directive 2001/83/EC or another proof of release to the
market in question based on an equivalent system should be carefully checked by
appropriately trained personnel.
5.5. Storage
Medicinal products and if necessary healthcare products should be stored separately
from other products likely to alter them and should be protected from the harmful
effects of light, temperature, moisture and other external factors. Particular attention
should be paid to products requiring specific storage conditions.
Incoming containers of medicinal products should be cleaned, if necessary, before
storage.
Warehousing operations must ensure appropriate storage conditions are maintained
and allow for appropriate security of stocks.
Stock should be rotated according to the first expiry, first out (FEFO) principle.
Exceptions should be documented.
Medicinal products should be handled and stored in such a manner as to prevent
spillage, breakage, contamination and mix-ups. Medicinal products should not be
stored directly on the floor unless the package is designed to allow such storage
(such as for some medicinal gas cylinders).
 Medicinal products that are nearing their expiry date / shelf life should be withdrawn
immediately from saleable stock either physically or through other equivalent
electronic segregation.
Stock inventories should be performed regularly taking into account national
legislation requirements. Stock irregularities should be investigated and documented.
5.6. Destruction of Obsolete Goods
Medicinal products intended for destruction should be appropriately identified, held
separately and handled in accordance with a written procedure.
Destruction of medicinal products should be in accordance with national or
international requirements for handling, transport and disposal of such products.
Records of all destroyed medicinal products should be retained for a defined period.
5.7. Picking
Controls should be in place to ensure the correct product is picked. The product
should have an appropriate remaining shelf life when it is picked.
5.8. Supply
For all supplies, a document (e.g. delivery note) must be enclosed stating the date;
name and pharmaceutical form of the medicinal product, batch number at least for
products bearing the safety features; quantity supplied; name and address of the
supplier, name and delivery address of the consignee16 (actual physical storage
premises, if different) and applicable transport and storage conditions. Records
should be kept so that the actual location of the product can be known.
5.9. Export to third countries
The export of medicinal products falls within the definition of ‘wholesale
distribution’17. A person exporting medicinal products must hold a wholesale
distribution authorisation or a manufacturing authorisation. This is also the case if the
exporting wholesale distributor is operating from a free zone.
The rules for wholesale distribution apply in their entirety in the case of export of
medicinal products. However, where medicinal products are exported, they do not
need to be covered by a marketing authorisation of the Union or a Member State18.
Wholesalers should take the appropriate measures in order to prevent these medicinal
products reaching the Union market. Where wholesale distributors supply medicinal
products to persons in third countries, they shall ensure that such supplies are only
made to persons who are authorised or entitled to receive medicinal products for
wholesale distribution or supply to the public in accordance with the applicable legal
and administrative provisions of the country concerned.

16
Article 82 of Directive 2001/83/EC.
17
Article 1(17) of Directive 2001/83/EC.
18
Article 85a of Directive 2001/83/EC
6. CHAPTER 6 – COMPLAINTS, RETURNS, SUSPECTED FALSIFIED MEDICINAL
PRODUCTS AND MEDICINAL PRODUCT RECALLS
6.1. Principle
All complaints, returns, suspected falsified medicinal products and recalls must be
recorded and handled carefully according to written procedures. Records should be
made available to the competent authorities. An assessment of returned medicinal
products should be performed before any approval for resale. A consistent approach
by all partners in the supply chain is required in order to be successful in the fight
against falsified medicinal products.
6.2. Complaints
Complaints should be recorded with all the original details. A distinction should be
made between complaints related to the quality of a medicinal product and those
related to distribution. In the event of a complaint about the quality of a medicinal
product and a potential product defect, the manufacturer and/or marketing
authorisation holder should be informed without delay. Any product distribution
complaint should be thoroughly investigated to identify the origin of or reason for the
complaint.
A person should be appointed to handle complaints and allocated sufficient support
personnel.
If necessary, appropriate follow-up actions (including CAPA) should be taken after
investigation and evaluation of the complaint, including where required notification
to the national competent authorities.
6.3. Returned Medicinal Products
Returned products must be handled according to a written, risk-based process taking
into account the product concerned, any specific storage requirements and the time
elapsed since the medicinal product was originally dispatched. Returns should be
conducted in accordance with national law and contractual arrangements between the
parties.
Medicinal products which have left the premises of the distributor should only be
returned to saleable stock if all of the following are confirmed:
i) the medicinal products are in their unopened and undamaged secondary packaging
and are in good condition; have not expired and have not been recalled;
ii) medicinal products returned from a customer not holding a wholesale distribution
authorisation or from pharmacies authorised to supply medicinal products to the
public should only be returned to saleable stock if they are returned within an
acceptable time limit, for example ten days;
iii) it has been demonstrated by the customer that the medicinal products have
been transported, stored and handled in compliance with their specific storage
requirements;
iv) they have been examined and assessed by a sufficiently trained and competent
person authorised to do so;
v) the distributor has reasonable evidence that the product was supplied to that
customer (via copies of the original delivery note or by referencing invoice numbers,
 etc.) and the batch number for products bearing the safety features is known, and that
there is no reason to believe that the product has been falsified.
Moreover, for medicinal products requiring specific temperature storage conditions
such as low temperature, returns to saleable stock can only be made if there is
documented evidence that the product has been stored under the authorised storage
conditions throughout the entire time. If any deviation has occurred a risk assessment
has to be performed, on which basis the integrity of the product can be demonstrated.
The evidence should cover:
i) delivery to customer
ii) examination of the product
iii) opening of the transport packaging
iv) return of the product to the packaging
v) collection and return to the distributor
vi) return to the distribution site refrigerator.
Products returned to saleable stock should be placed such that the ‘first expired first
out’ (FEFO) system operates effectively.
Stolen products that have been recovered cannot be returned to saleable stock and
sold to customers.
6.4. Falsified Medicinal Products
Wholesale distributors must immediately inform the competent authority and the
marketing authorisation holder of any medicinal products they identify as falsified or
suspect to be falsified19. A procedure should be in place to this effect. It should be
recorded with all the original details and investigated.
Any falsified medicinal products found in the supply chain should immediately be
physically segregated and stored in a dedicated area away from all other medicinal
products. All relevant activities in relation to such products should be documented
and records retained.
6.5. Medicinal Product Recalls
The effectiveness of the arrangements for product recall should be evaluated
regularly (at least annually).
Recall operations should be capable of being initiated promptly and at any time.
The distributor must follow the instructions of a recall message, which should be
approved, if required, by the competent authorities.
Any recall operation should be recorded at the time it is carried out. Records should
be made readily available to the competent authorities.
The distribution records should be readily accessible to the person(s) responsible for
the recall, and should contain sufficient information on distributors and directly
supplied customers (with addresses, phone and/or fax numbers inside and outside
working hours, batch numbers at least for medicinal products bearing safety features
as required by legislation and quantities delivered), including those for exported
products and medicinal product samples.
19
Article 80(i) of Directive 2001/83/EC.
The progress of the recall process should be recorded for a final report.
7. CHAPTER 7 – OUTSOURCED ACTIVITIES
7.1. Principle
Any activity covered by the GDP Guide that is outsourced should be correctly
defined, agreed and controlled in order to avoid misunderstandings which could
affect the integrity of the product. There must be a written Contract between the
Contract Giver and the Contract Acceptor which clearly establishes the duties of each
party.
7.2. Contract Giver
The Contract Giver is responsible for the activities contracted out.
The Contract Giver is responsible for assessing the competence of the Contract
Acceptor to successfully carry out the work required and for ensuring by means of
the contract and through audits that the principles and guidelines of GDP are
followed. An audit of the Contract Acceptor should be performed before
commencement of, and whenever there has been a change to, the outsourced
activities. The frequency of audit should be defined based on risk depending on the
nature of the outsourced activities. Audits should be permitted at any time.
The Contract Giver should provide the Contract Acceptor with all the information
necessary to carry out the contracted operations in accordance with the specific
product requirements and any other relevant requirements.
7.3. Contract Acceptor
The Contract Acceptor should have adequate premises and equipment, procedures,
knowledge and experience, and competent personnel to carry out the work ordered
by the Contract Giver.
The Contract Acceptor should not pass to a third party any of the work entrusted to
him under the contract without the Contract Giver’s prior evaluation and approval of
the arrangements and an audit of the third party by the Contract Giver or the Contract
Acceptor. Arrangements made between the Contract Acceptor and any third party
should ensure that the wholesale distribution information is made available in the
same way as between the original Contract Giver and Contract Acceptor.
The Contract Acceptor should refrain from any activity which may adversely affect
the quality of the product(s) handled for the Contract Giver.
The Contract Acceptor must forward any information that can influence the quality
of the product(s) to the Contract Giver in accordance with the requirement of the
contract.
8. CHAPTER 8 – SELF-INSPECTIONS
8.1. Principle
Self-inspections should be conducted in order to monitor implementation and
compliance with GDP principles and to propose necessary corrective measures.
8.2. Self-Inspections
A self-inspection programme should be implemented covering all aspects of GDP
and compliance with the regulations, guidelines and procedures within a defined time
frame. Self-inspections may be divided into several individual self-inspections of
limited scope.
Self-inspections should be conducted in an impartial and detailed way by designated
competent company personnel. Audits by independent external experts may also be
useful but may not be used as a substitute for self-inspection.
All self-inspections should be recorded. Reports should contain all the observations
made during the inspection. A copy of the report should be provided to the
management and other relevant persons. In the event that irregularities and/or
deficiencies are observed, their cause should be determined and the corrective and
preventive actions (CAPA) should be documented and followed up.
9. CHAPTER 9 – TRANSPORTATION
9.1. Principle
It is the responsibility of the supplying wholesale distributor to protect medicinal
products against breakage, adulteration and theft, and to ensure that temperature
conditions are maintained within acceptable limits during transport.
Regardless of the mode of transport, it should be possible to demonstrate that the
medicines have not been exposed to conditions that may compromise their quality
and integrity. A risk-based approach should be utilised when planning transportation.
9.2. Transportation
The required storage conditions for medicinal products should be maintained during
transportation within the defined limits as described by the manufacturers or on the
outer packaging.
If a deviation such as temperature excursion or product damage has occurred during
transportation, this should be reported to the distributor and recipient of the affected
medicinal products. A procedure should also be in place for investigating and
handling temperature excursions.
It is the responsibility of the wholesale distributor to ensure that vehicles and
equipment used to distribute, store or handle medicinal products are suitable for their
use and appropriately equipped to prevent exposure of the products to conditions that
could affect their quality and packaging integrity.
There should be written procedures in place for the operation and maintenance of all
vehicles and equipment involved in the distribution process, including cleaning and
safety precautions.
Risk assessment of delivery routes should be used to determine where temperature
controls are required. Equipment used for temperature monitoring during transport
within vehicles and/or containers, should be maintained and calibrated at regular
intervals at least once a year.
Dedicated vehicles and equipment should be used, where possible, when handling
medicinal products. Where non-dedicated vehicles and equipment are used
procedures should be in place to ensure that the quality of the medicinal product will
not be compromised.
Deliveries should be made to the address stated on the delivery note and into the care
or the premises of the consignee. Medicinal products should not be left on alternative
premises.
For emergency deliveries outside normal business hours, persons should be
designated and written procedures should be available.
Where transportation is performed by a third party, the contract in place should
encompass the requirements of Chapter 7. Transportation providers should be made
aware by the wholesale distributor of the relevant transport conditions applicable to
the consignment. Where the transportation route includes unloading and reloading or
transit storage at a transportation hub, particular attention should be paid to
temperature monitoring, cleanliness and the security of any intermediate storage
facilities.
 Provision should be made to minimise the duration of temporary storage while
awaiting the next stage of the transportation route.
9.3. Containers, Packaging and Labelling
Medicinal products should be transported in containers that have no adverse effect on
the quality of the products, and that offer adequate protection from external
influences, including contamination.
Selection of a container and packaging should be based on the storage and
transportation requirements of the medicinal products; the space required for the
amount of medicines; the anticipated external temperature extremes; the estimated
maximum time for transportation including transit storage at customs; the
qualification status of the packaging and the validation status of the shipping
containers.
Containers should bear labels providing sufficient information on handling and
storage requirements and precautions to ensure that the products are properly handled
and secured at all times. The containers should enable identification of the contents
of the containers and the source.
9.4. Products Requiring Special Conditions
In relation to deliveries containing medicinal products requiring special conditions
such as narcotics or psychotropic substances, the wholesale distributor should
maintain a safe and secure supply chain for these products in accordance with
requirements laid down by the Member States concerned. There should be additional
control systems in place for delivery of these products. There should be a protocol to
address the occurrence of any theft.
Medicinal products comprising highly active and radioactive materials should be
transported in safe, dedicated and secure containers and vehicles. The relevant safety
measures should be in accordance with international agreements and national
legislation.
For temperature-sensitive products, qualified equipment (e.g. thermal packaging,
temperature-controlled containers or temperature controlled vehicles) should be used
to ensure correct transport conditions are maintained between the manufacturer,
wholesale distributor and customer.
If temperature-controlled vehicles are used, the temperature monitoring equipment
used during transport should be maintained and calibrated at regular intervals.
Temperature mapping under representative conditions should be carried out and
should take into account seasonal variations.
If requested, customers should be provided with information to demonstrate that
products have complied with the temperature storage conditions.
If cool-packs are used in insulated boxes, they need to be located such that the
product does not come in direct contact with the cool-pack. Staff must be trained on
the procedures for assembly of the insulated boxes (seasonal configurations) and on
the re-use of cool-packs.
There should be a system in place to control the re-use of cool-packs to ensure that
incompletely cooled packs are not used in error. There should be adequate physical
segregation between frozen and chilled ice packs.
The process for delivery of sensitive products and control of seasonal temperature
variations should be described in a written procedure.
10. CHAPTER 10 – SPECIFIC PROVISIONS FOR BROKERS20
10.1. Principle
A ‘broker’ is 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 person21.
Brokers are subject to a registration requirement. They must have a permanent
address and contact details in the Member State where they are registered22. They
must notify the competent authority of any changes to those details without
unnecessary delay.
By definition, brokers do not procure, supply or 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 which ensures 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 for the medicinal product concerned23. The competent
authorities must be immediately informed of any suspected falsified medicines
offered in the supply chain24.
10.3. Personnel
Any member of personnel involved in the brokering activities should be trained in
the applicable EU and national legislation and in the issues concerning falsified
medicinal products.
10.4. Documentation
The general provisions on documentation in Chapter 4 apply.
In addition, at least the following procedures and instructions, along with the
corresponding records of execution, should be in place:
i) procedure for complaints handling;
ii) procedure for informing competent authorities and marketing authorisation
holders of suspected falsified medicinal products;
iii) procedure for supporting recalls;

20
Article 85b(3) of Directive 2001/83/EC.
21
Article 1(17a) of Directive 2001/83/EC.
22
Article 85b of Directive 2001/83/EC
23
Article 80(d) of Directive 2001/83/EC.
24
Article 85b(1), 3rd subparagraph of Directive 2001/83/EC.
iv) procedure for ensuring that medicinal products brokered have a marketing
authorisation;
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 kept 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.
11. CHAPTER 11 – FINAL PROVISIONS
These Guidelines replace the Guidelines on Good Distribution Practice of Medicinal Products
for Human Use, published on 1 March 199425 and the Guidelines of 7 March 2013 on Good
Distribution Practice of Medicinal Products for Human Use26.

These Guidelines will be applied from the first day following their publication in the Official
Journal of the European Union.

25
OJ C 63, 1.3. 1994, p. 4.
26
OJ C 68, 8. 3. 2013, p. 1.
Annex

Glossary of Terms

Terms Definition
Good Distribution GDP is that part of quality assurance which ensures that the
quality of medicinal products is maintained throughout all
Practice (GDP)
stages of the supply chain from the site of manufacturer to
the pharmacy or person authorised or entitled to supply
medicinal products to the public.
Export procedure Export procedure: Allow Community goods to leave the
customs territory of the Union. For the purpose of these
guidelines, the supply of medicines from EU Member State
to a contracting State of the European Economic Area is not
considered as export.

Falsified medicinal Any medicinal product with a false representation of:

product27 (a) its identity, including its packaging and labelling, its
name or its composition as regards any of the ingredients
including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of
manufacturing, its country of origin or its marketing
authorisation holder; or
(c) its history, including the records and documents
relating to the distribution channels used.

27
Article 1(33) of Directive 2001/83/EC.
 Free zones and free Free zones and free warehouses are parts of the customs
warehouses28 territory of the Community or premises situated in that
territory and separated from the rest of it in which:
(a) Community goods are considered, for the purpose of
import duties and commercial policy import measures, as
not being on Community customs territory, provided they
are not released for free circulation or placed under another
customs procedure or used or consumed under conditions
other than those provided for in customs regulations;
(b) Community goods for which such provision is made
under Community legislation governing specific fields
qualify, by virtue of being placed in a free zone or free
warehouse, for measures normally attaching to the export
of goods.
Holding Storing medicinal products

Transport Moving medicinal products between two locations without

storing them for unjustified periods of time
Procuring Obtaining, acquiring, purchasing or buying medicinal
products from manufacturers, importers or other wholesale
distributors
Qualification Action of proving that any equipment works correctly
and actually leads to the expected results.
The word validation is sometimes widened to incorporate
the concept of qualification.
(Defined in EudraLex Volume 4 Glossary to the GMP
Guidelines)

Supplying All activities of providing, selling, donating medicinal

products to wholesalers, pharmacists, or persons authorised
or entitled to supply medicinal products to the public.
Quality Risk A systematic process for the assessment, control,
communication and review of risks to the quality of the
Management
drug (medicinal) product across the product lifecycle.

Quality System The sum of all aspects of a system that implements quality
policy and ensures that quality objectives are met.
(International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use, Q9)

28
Articles 166 to 181 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the
Community Customs Code., OJ L 302, 19.10.1992, p. 1.
Validation Action of proving that any procedure, process,
equipment, material, activity or system actually leads to
the expected results (see also Qualification).
(Defined in EudraLex Volume 4 Glossary to the GMP
Guidelines)