BEST PRACTICE TO OPTIMISE

CONTINUITY OF MEDICINES
SUPPLY
(April 2008)

INTRODUCTION
The purpose of this document is to outline the procedures which companies should
follow in the event of withdrawals or shortages to meet their regulatory obligations
and to minimise the difficulties which can arise in such situations.
WITHDRAWALS/STOCK SHORTAGES
There are three situations where withdrawals arise:
1.

The company decides to take the medicine off the market because of falling
sales, problems maintaining joint packs, manufacturing issues, etc.

2.

The product is being withdrawn because of a quality, safety or efficacy issue,

either voluntarily by the company or because the regulatory authority has
requested that this be done. In either case, there will be close liaison with the
IMB and discussion regarding the arrangements for the withdrawal of the
product and the notification of health professionals. It is also advisable to
discuss what information, if any, will be released to the public by the IMB, e.g.,
a press release.

3.

The product is being sold off to another company. Difficulties arise here if it
becomes temporarily unavailable after the marketing authorisation has been
transferred.

In addition, companies may experience temporary or prolonged stock shortages,

which may or may not be foreseeable.
WHO TO NOTIFY
IPHA has prepared a separate Continuity of Supply Contact List with names,
addresses, phone numbers etc. to accompany this Best Practice guide.

1.

IRISH MEDICINES BOARD

Under the Medicinal Products (Licensing and Sale) Regulations, 1998, companies
are legally required to notify the IMB of the withdrawal of products from the market
and to give reasons for the withdrawal. The relevant extract from the Regulations is
set out below:
First Schedule, Part II General Conditions Applicable to Authorisations
11.

The authorisation holder shall notify the Board of any decision to withdraw
from sale or supply any preparation to which the authorisation relates and
shall state the reason for that decision.

The Regulations do not specify at what stage the IMB has to be notified, however, it
is recommended that the IMB be notified as soon as the company decides to
withdraw the medicine. The IMB must be notified that a medicine is being taken
off the market even if the company intends to maintain the marketing
authorisation.
The IMB has requested that notification be sent to the Post-Licensing Manager who
will ensure that all relevant departments are notified.
The notification to the IMB must specify:

Details of the product or products to be withdrawn from the market, in particular

the marketing authorisation number(s).
The expected date of withdrawal of the product from the market.
In the case of nationally authorised products, whether or not the company also
wishes to have the product authorisation revoked and the date on which the PA
should be revoked by the IMB.

If a company is aware that a medicine is likely to go out of stock temporarily during its
transfer to another company, it is strongly recommended that interim arrangements
by way of batch specific variation (e.g. overlabelling of stock from other markets) be
agreed with the IMB to ensure continuity of supply.
Where an urgent recall is necessary, the company must contact the IMB as a matter
of urgency regarding the arrangements for same. An out-of-hours contact number is
available for this purpose.
Please note that these requirements will change once the forthcoming
regulations arising from the EU review of pharmaceutical legislation are
transposed into Irish law and this document will be updated again at that
point.1
1

Note: The following documents Guide to Withdrawal of Authorisations or Certificates for Medicinal
Products for Human Use version 2 October 2005 and Notification of withdrawal of authorisation or
certificates for Medicinal Products for Human Use, prepared by the IMB, are available on the IMB website.
These were produced in anticipation of the making of the regulations by the 30 October 2005. The regulations
have not yet been enacted into law and therefore these Guidelines and notifications are not currently applicable
(see section 3 of the IMBs Transitional Arrangements for Directive 2004/27/EC and 2004/24/EC document
which states that Articles 23 a, paragraphs 1 and 2 [of the Directive] which require notification of the date of
2

2.

HEALTH SERVICE EXECUTIVE (HSE)

The IPHA/HSE Agreement for the Supply of Medicines to the Health Services
specifically requires advance notification to the HSE of various situations (set out
below) which could give rise to continuity of supply problems.
The relevant section of the Agreement is Clause 9 and it first sets out the overall
objective in this area:
Continuity of supply is recognised by both parties to this Agreement as crucially
important to the effective operation of arrangements for the supply of medicines
to Irish patients. Equally, it is recognised that from time to time interruptions to
supply may arise, which are outside the control of the manufacturer, importer or
agent.
(a) Foreseeable or Prolonged Stock Shortages
Manufacturers, importers or their agents, who experience foreseeable or prolonged
stock shortages, or the possibility of such shortages, must notify the HSE as soon as
they become aware of the problem, using the official form (set out in Appendix 1 to
the Agreement and included with this document for convenience).
The Agreement stipulates that the supplier shall endeavour to source an alternative
supply to alleviate the shortage.
(b) Withdrawal of Medicines
In the interest of an uninterrupted supply of medicines to patients, manufacturers,
importers or their agents who intend to withdraw medicines from the market must
provide notice to the HSE of their intention to do so using the official form (set out in
Appendix 2 to the Agreement and included with this document for convenience).
(i)

A notice period of at least 12 months must be given for the withdrawal of

medicines for which there is no reimbursable therapeutic alternative for
approved indications.

(ii)

A notice period of at least 3 months must be given for the withdrawal of

medicines for which there is a reimbursable therapeutic alternative for
approved indications.

The Agreement does not define what is meant by therapeutic alternative. This is
determined on a case by case basis.
This form (rather than a letter) should be used to notify all withdrawals to the HSE.
Please send the form to the HSE by e-mail using the e-mail address provided in the
Withdrawals Contact List.
(c) Transfer of a Marketing Authorisation to another manufacturer
marketing and of ca cessation in marketing will only take effect on the date of making of the regulations.
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Where the transfer of a Marketing Authorisation is likely to materially change the

arrangements for the supply of a medicine, the original MA holder must provide at
least 3 months notice to the HSE of the transfer of the authorisation, using the
official form (set out in Appendix 3 to the Agreement and included with this document
for convenience).
The Agreement stipulates that where a supplier is in breach of this Clause of the
Agreement it shall be required to either source and supply alternative equivalent
products at the same price as the unavailable product or reimburse the HSE any
difference in cost arising from the shortage. (The HSE will consult the IPHA in relation
to any such cases).
3.

PRIMARY CARE REIMBURSEMENT SERVICE (PCRS)

The Primary Care Reimbursement Service (PRCS), formerly known as the GMS
(Payments) Board, notifies doctors and pharmacists of products being added to and
deleted from the Community Drugs Schemes. For this reason, it is important that it
be notified as soon as possible of the withdrawal of a medicine. The following
information must be provided:
4.

Date of discontinuation of the product.

Expiry date of the last manufactured batch of the product.
Expected date of depletion of stocks.
NATIONAL MEDICINES INFORMATION CENTRE

Doctors and pharmacists frequently contact the National Medicines Information

Centre (NMIC) with queries about medicines which have been withdrawn. It is
therefore important that the NMIC be notified about a withdrawal as the earliest
opportunity so they can investigate alternatives and be in a position to deal with the
queries.
The NMIC has indicated that a pharmaceutical company may refer health
professionals to them for advice on alternatives provided that this has been agreed in
advance with the NMIC. In addition, referrals to the NMIC should only be made by
the company in response to a query following the letter of notification of the
withdrawal. In no circumstances, should the notification of the withdrawal refer
healthcare professionals directly to the NMIC for information/advice.
Note: The NMIC does not accept queries from members of the public.
5.

HEALTH PROFESSIONALS

Doctors and pharmacists should be made aware of all withdrawals and foreseeable
prolonged stock shortages of medicinal products from the Irish market. Other

healthcare professionals should be informed as appropriate, e.g. dentists in the case

of products which are routinely used in dental practice.
The method of notification used will vary from medicine to medicine and will be
influenced by factors such as the level of usage of the medicine, the number of
alternatives available and so on.

Dear Doctor letters

In certain circumstances, companies will need to notify withdrawals immediately
by way of Dear Doctor and Dear Pharmacist letters, e.g. if an urgent safety
problem has arisen or if the product is to be withdrawn within a very short
timeframe which might cause problems for patients. Where there is a safety or
efficacy issue, the wording of such letters will usually have to be agreed with the
IMB.
In the case of a general mailing to the medical and pharmacy professions, it is
important that the mailing lists used are up-to-date so that no-one is overlooked.
Dear Doctor letters also have a role where, for example, a product is only used
by a limited number of doctors or hospitals. In this case, a letter to the relevant
people might be more effective than a general announcement in the media and is
likely to be appreciated.

Press announcements
Most routine withdrawals can be notified by way of announcements in the medical
and pharmacy press. To ensure maximum coverage, send press releases to all
medical and pharmacy publications:
-

Irish Medical News

Irish Medical Times
Medicine Weekly
Forum*
Modern Medicine*
Hospital Doctor*
Irish Pharmacy Journal*
IPU Review*
Irish Pharmacist*

* - monthly publication therefore need to allow for longer lead-in times.

Not all press releases are published because of pressure on space. It is therefore
advisable to follow up with the relevant publications to maximise the likelihood of
publication. If possible, arrange for notices of withdrawals to be run in more than
one issue.

Medical representatives
Medical representatives also have a role to play in making health professionals
aware of withdrawals/shortages. They are ideally placed to deal with queries from
doctors and pharmacists on withdrawals and need appropriate information to be
in a position to do so.

MIMS
A discontinuation notice in the New This Month section in MIMS should not be
used as the sole means of notifying prescribers about withdrawals, although it is
useful for reinforcing other notifications such as Dear Doctor letters or
announcements in the medical and pharmacy press.
In any case, ensure that the entry for a product in MIMS is deleted when it is
withdrawn.

Irish Pharmacy Union

The Irish Pharmacy Union (IPU) produces a monthly General Memorandum for
members and will include details of withdrawals/shortages if asked to do so. This
memorandum is also published on the members section of the IPU website.
The IPU also maintains a comprehensive product file database which is used by
several pharmacy, GP and hospital software system vendors.
Send the notification of the withdrawal/shortage to the IPU so that details can be
included in the monthly bulletin for members and the necessary amendment
made to the IPUs product file.

Pharmacy & medical system vendors

Software system vendors who have their own product files (rather than using the
IPU database) should be notified separately about a product being withdrawn.

Websites for healthcare professionals

An additional means of notifying withdrawals/shortages to doctors and
pharmacists is to forward details to websites aimed specifically at healthcare
professionals.

6.

WHOLESALERS

As well as your primary distributor, notify all wholesalers of withdrawals/shortages

and give an indication as to the expected timetable.

WHEN TO NOTIFY
As stated above, a company must notify the HSE within set notice periods in
circumstances which may affect continuity of supply.
Other parties should be notified about such situations at the earliest possible
opportunity, i.e., as soon as the company is aware of the withdrawal/shortage.
This is particularly important for:
-

lifesaving medicines such as those used on emergency trolleys etc.

medicines used on an ongoing basis on a repeatable prescription. Rather than
having patients caught unaware when stocks are exhausted, pharmacists should
be asked to give advance warning to patients when they have their monthly
supply dispensed so that they can visit their doctor and make alternative
arrangements.

CONTENT OF GENERAL NOTIFICATION FOR WITHDRAWALS

Information to be included:

Name of product to be notified (if it is part of a range, specify if the other

products are to remain on the market. Similarly if the product or products are
being replaced by a new product or range, include details).
Timetable for withdrawal (including an indication of when stocks are expected
to be fully exhausted).
Details of any interim arrangements (e.g. named patient supplies).
In relation to shortages an estimate, if possible, of the likely timescale within
which normal supply will be resumed.
Who to contact in the company for further information (name, telephone no.
etc). Ideally provide an Irish phone number or a free-phone number so that
health professionals looking for further information do not have to incur the
cost of a call to the UK.

In addition, consider including details of why the medicine has been withdrawn. If
the product is being sold off to another company, it would be helpful to include
details of that company and indicate when it is likely to be available again (if this
information is available).
It is not appropriate to refer prescribers to MIMs for alternatives.
COMPANY PROCEDURES
Companies should have standard operating procedures for the withdrawal of
medicines, which ensure that a comprehensive plan is put in place for the
management of each withdrawal. Involve all key personnel (Managing Director,
Sales/Marketing, Medical/Regulatory etc.) in the process.
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Any notification of a withdrawal is likely to lead to a considerable number of queries

to the company. It is therefore important to ensure that the relevant personnel are
available so that all queries can be dealt with promptly and thoroughly.
ACCOMPANYING DOCUMENTS
The following documents accompany this Best Practice guide:

IPHA Continuity of Supply Contact List

HSE Notification Forms (3 different types)
Guidance Notes on HSE Withdrawals Form