[e-med] Mission pour un pharmacien au Kosovo

[darmstaedter@ibf.be]

E-MED: Mission pour un pharmacien au Kosovo
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[Modérateur: ils recherchent d'urgence un pharmacien, 15 ans d'expérience
pour une mission de 100 jour au Kosovo.CB]

Dear Madam/Sir,
We take the opportunity to contact you as part of our work for the European
Commission under the Framework Contract for Development of the Social
Sector.  We are urgently looking forward for one expert to work in Kosovo.
I would like to know if you are interested in this mission. If not, do you
know someone with this profile?

Mission in Kosovo:

Starting date : 2 February 2004

Duration of the assignment:

*	1 EU Expert  - Category I (at least 15 years of experience) - Doctor or
Pharmacyst - 100 days

I look forward to hearing from you soon.

With kind regards,

Frédérique Darmstaedter (Ms.)
Project Administrator
Framework Contract Unit
darmstaedter@ibf.be

IBF International Consulting
Avenue de Tervueren 72
1040 Brussels

tel. (general) +32 (0)2 237 0900
tel. (direct line) +32 (0)2 237 09 05
fax +32 (0)2 230 46 49
http://www.ibf.be

****************

TERMS OF REFERENCE

International Advisor to the Kosovo Medicines Agency and the Pharmaceutical
Division in the Ministry of Health, Kosovo

1.	BACKGROUND

Kosovo has had to develop since 2000 a pharmaceutical regulatory and policy
framework from effectively a zero basis with the eventual objective of
achieving European standards. The Agency established for the regulatory
control of medicinal drugs, is the Kosovo Medicines Agency (KMA), which was
established in 2001 through EC funding.  Its responsibilities include
overseeing efficacy, efficiency and safety of the pharmaceutical products
within the province of Kosovo. The KMA has set it self the objective of
achieving EU standards of pharmaceutical regulation by end of 2006 (?The KMA
2006 objective?).
Likewise, The Pharmaceutical Division (PD) was created within the structure
of the Ministry of Health, under the Provisional Institutions of Self
Government (PISG), in 2002 and following the approval of the Ministry of
Health organogramme. The PD is responsible for the overall pharmaceutical
policy within the Ministry of Health and includes financing, pricing and
payment schemes, rational utilization and a public sector pharmaceutical
supply system.

During the period between 2002 and 2003 a number of key pharmaceutical
regulatory instruments have  come into force with the support of EC funding.

1.  Kosovo Law on Medicinal Products and Medical Devices (?Medicines Law?)

On 5th December, 2003 the law passed its final reading in the Assembly of
Kosovo and has now been submitted to the United Nations Mission in Kosovo
(UNMIK) Special Representative of the Secretary General (SRSG) for
promulgation. It is anticipated that the Law will come into force at the end
of January/early February 2004 and will thus mark an important step in the
development of the Kosovo pharmaceutical sector. The promulgation of this
law will lead to the next stage  of pharmaceutical regulatory development in
Kosovo that concerns the drafting and implementation of a number of
Normative Acts (NAs) that will be pursuant to this Law on Medicinal Products
and Medical Devices.

2. Provisional Marketing Authorisation (PMA) of medicinal products system
Kosovo is currently the only territory in Europe with no requirement for
registration (marketing authorization -MA) of medicinal products. Thus the
following provisional system has been introduced in this period in order to
provide a transitional system before implementation of a Full MA system.
The Provisional Marketing Authorisation (PMA) system is an 18 month
transitional system prior to implementation of the Full Marketing
Authorisation (FMA) system.

3. Pharmacy licensing

The MoH Administrative Instruction (AI) ?On Licensing of Pharmacies in
Kosovo? came into force in May 2003. This AI was drafted in order to provide
an enforcement solution to the existing widespread unlicensed pharmacy
problem in Kosovo.

A memorandum of understanding (MoU),setting out precise collaboration
between the KMA and the Pharmaceutical Division has been negotiated and
signed.

Staff in both KMA and PD have been trained on the job and through
participation in international training programmes.. Most staff have been in
their respective offices a relatively short time and lack the capacity to
build up and further develop institutional capacity on their own.
International expertise in capacity and institution building has become
necessary as complex procedures in the public drug management cycle are not
yet well established within the MoH and KMA.
Following the completion of the current programme of EAR support to the
Kosovo pharmaceutical sector at end of 2003, further support is required in
implementing pharmaceutical regulation and policy in Kosovo for 2004.

2.	Description of the assigment
Ø	Beneficiary(ies)
Ministry of Health, Kosovo Medicines Agency, Pharmaceutical Division
Ø	Global and specific objectives
Ø	Global objectives
To conclude and to consolidate the EC support to the development of the
public pharmaceutical sector in Kosovo to date and to ensure the sustained
legislative and normative function of the Kosovo Medicines Agency and the
Pharmaceutical Division at the Ministry of Health.

Ø	Specific objectives

1. To support the Kosovo Medicines Agency (KMA) in its process to achieve
basic EU standards in pharmaceutical regulation by the end of 2006 in
accordance with the provisions of the Kosovo Law on Medicinal Products &
Medical Devices (Medicines Law) that has been approved by the Kosovo
Assembly in December 2003 and is due for promulgation by the UNMIK SRSG in
early 2004.
2. To support the MoH Pharmaceutical Division (MoH PD) to introduce systems
for pricing, reimbursement and prescribing control of medicinal products.
3. To support the introduction of effective co-ordination procedures between
(i) the UNMIK and PISG authorities and (ii) Kosovo authorities and relevant
international bodies in pharmaceutical regulation and policy and narcotics
control, with the view of ultimate transfer of authority from UNMIK to PISG
in the area of pharmaceutical regulation.

Ø	Requested services
 The consultant will

1.	Assist in the amendment of the Medicines Law, as requested by the Kosovo
Assembly Health Committee for the presentation to the UNMIK Office of the
Legal Advisor (OLA). The amendments are necessary its promulgation by the
SRSG;
2.	Support the drafting of Normative Acts pursuant to the Kosovo Medicines
Law, including organisational and resources provisions for the
implementation of such acts;

3.	Support the implementation of the Kosovo Provisional Marketing
Authorisation (PMA) system and the transition to a Full Marketing
Authorisation (FMA system);

4.	Provide training support to KMA and MoH PD professional staff enrolled in
MSc distance learning courses in the area of pharmaceutical regulation and
policy (i.e. pharmaceutical regulatory affairs, pharmacovigilance and drug
pricing and reimbursement);

5.	Provide technical assistance in the resolution of the KMA self-financing
funding statutes and in its status as an executive authority of the Kosovo
government by mid 2004;

6.	Support the MoH in implementing the drug pricing, financing,
reimbursement and prescribing legislation and system implementation;

7.	Provide training to customs officers of the Kosovo Customs Service in
areas related to the pharmaceutical regulation and narcotics control in
Kosovo such as the regulatory requirements for import, transit and export of
medicinal products (including the provisions of the UN International
Narcotics Control Board relating to control of narcotics, psychotropics and
their precursors);

8.	Assist in the preparation for the presentation of EC projects in support
to the Pharmaceutical Sector at the end of April 2004 on a Health Sector
conference in Pristina.

Ø	Expected results
At the end of the assignment the consultant will have successfully assisted
in the:
1.	EC assistance for putting into force of the Kosovo Medicines Law;
2.	Development of the final drafts of Normative Acts pursuant to the Kosovo
Medicines Law (concerning medicinal products);
3.	Implementation of the Kosovo PMA system in its entirety and satisfactory
provisions for the implementation of the Kosovo Full Marketing Authorisation
system
4.	Demonstration of ongoing satisfactory support to the training needs of
KMA and MoH PD (both MSc distance learning students and other student
placements) and to sector regulatory stakeholders such as the Kosovo Customs
Service
5.	Solution of the KMA self-financing status issue and the implementation of
the KMA management board;
6.	Demonstrable progress of implementing the Kosovo system for
pharmaceutical pricing, financing, reimbursement, prescribing and dispensing
(i.e. implementation of appropriate legislation and systems);
7.	Presentation of EAR results in support to the Kosovo Pharmaceutical
Sector (2000-2003) at the EAR Health Sector Conference April 2004.

3.	Experts profile
Ø	Education, experience, references and category of each expert
The international Category I expert will have university education in a
medical or pharmaceutical field and a relevant postgraduate degree.

Preferably at least 15 years related extensive demonstrated professional
experience  in the development, organization and management of
Pharmaceuticals and the capacity building process of pharmaceutical units
within central health administrations. Experience in licensing of
pharmaceuticals and regulatory affairs is desirable. Working experience in
the Balkans would be an additional asset.
It is expected that the expert will work in Kosovo for 100% of the allocated
time.

Ø	Working languages
The working language is English.

4.	Location and duration
5.	The total duration of the assignment will be 100 calendar days.
Ø	Starting date
2 February until 25 February 2004 (24)
1. March until 23. March 2004 (23)
13. April until 30. April 2004 (18)
10 May until 29 May 2004 (20)
7 June until 21 June 2004 (15)

Ø	Finishing date of the assignment
30 June 2004

Ø	Location of assignment
Ministry of Health, Kosovo Medicines Agency,Pristina, Kosovo

6.	Reporting
Ø	Content, language, format and number of reports
The expert is expected to provide a inception report after four weeks of his
assignment and then 2 monthly reports until the end of the contract. A final
report is expected within four weeks after the completion of the contract.
Ø	Date of submission
The final report is expected to be submitted by 21 July , 2004.

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