Procurement Summary
Country : Fiji
Summary : Consultancy- develop medicine regulation
Deadline : 15 Jun 2018
Other Information
Notice Type : Tender
TOT Ref.No.: 24125105
Document Ref. No. : Consultant
Competition : ICB
Financier : United Nations Secretariat
Purchaser Ownership : -
Tender Value : Refer Document
Purchaser's Detail
Purchaser : WORLD HEALTH ORGANIZATION
Fiji,
Tel: 00679-3304600 ext(3304600),
Fax: 00679-3234166,
Attn: Asaeli, Raikabakaba
Fiji
Email :wpfjidpsprocurement@who.int
Tender Details
Consultancy- Develop Medicine Regulation
Deadline: 15-Jun-2018 17:00
Time zone: (GMT 13.00) Auckland, Wellington, Fiji, Kamchatka
Description:
RE-ADVERTISED
Purpose of the Consultancy
To develop medicines regulations that will support the implementation of the Pharmacy Profession Act 2011 and the Medicinal Products Act 2011 in Fiji.
Background
Strengthening regulations and legal frameworks for pharmaceutical systems will ensure improved access to quality medicines for the population. Fiji has been working on strengthening its national regulatory authorities to enforce and implement its pharmacy laws and wishes to continue so. WHO has initially supported the Fiji Government in drafting the current enacted Fiji Pharmacy Profession Act 2011 and Fiji Medicinal Products Act 2011. There are also four regulations that has been drafted but never enacted, as follows:
Medicine Regulations,
Device Regulation,
Advertisement Regulation, and
Scheduling Regulation.
Additionally, there are four regulations from the repealed Pharmacy & Poisons Act Cap 115 with its specific Schedules that are still in used:
Pharmacy and Poisons (Manufacturing and Wholesale Licensing) Regulations which has six (6) Schedules,
Poisons (Industrial and Agricultural) Regulation which has 3 Schedules,
Poisons Regulations with 21 Schedules, and
Pharmacist Registration in Fiji Regulation.
The medicine regulatory authorities in Fiji continue to face enforcement challenges due to the gaps in the current law and regulations that are not addressing the use and control of medicinal products and practice adequately. Therefore, there is a need to develop new regulation(s) based on the assessment and consultation with key stakeholders, as well as to harmonize them with all other existing legislation.
Planned timelines (subject to confirmation)
Start date: July/August 2018
End date: July/August 2018 (20 working days)
Work to be performed
Method(s) to carry out the activity
Review the current Fiji Pharmacy Profession Act 2011 and Fiji Medicinal Products Act 2011 and other draft/enacted pharmacy regulations including the repealed Pharmacy & Poisons Act Cap 115
Conduct face-face interviews with key stakeholders
Collect relevant information and data based on the review and interviews
Identify the gaps and develop appropriate regulation(s)
Conduct stakeholders meeting on the findings of the review, new regulation(s) and its application in Fiji
Coordinate with technical staff of WHO/DPS the findings and recommendations of the review
Consolidate final report of the overall review with recommendations on the implementation of the new regulation(s)
Output/s
Output: Completion of review of Fiji Pharmacy Profession Act 2011 and Fiji Medicinal Products Act 2011 and other draft/enacted pharmacy regulations including the repealed Pharmacy & Poisons Act Cap 115
Deliverable 1: New regulation(s) developed
Deliverable 2: Final technical report highlighting key findings and recommendations for MOHMS, including a plan on how to implement the new regulation(s)
Technical Supervision
The selected Consultant will work on the supervision of:
Responsible Officer: Mr Asaeli Raikabakaba, Technical Officer – EMT, PHS, WHO/DPS
Email: raikabakabaa@who.int
Manager: Ms Martina Pellny, Team Coordinator – PHS, WHO/DPS
Email: pellnym@who.int
Specific requirements
- Qualifications required:
University degree in law with background in pharmacy or health science in general
- Experience required:
At least 7 years of relevant experience in reviewing and developing/drafting pharmacy law and regulations in low/middle income countries, some of which should have been obtained in an international context.
- Skills / Technical skills and knowledge:
Demonstrated expertise and good knowledge on pharmaceutical regulatory system and framework. Have a fair understanding about overall pharmaceutical system, procurement and management of medicines. Experience with desk research and report writing
- Language requirements:
Fluent in English
Competencies
Teamwork, Respecting and promoting individual and cultural differences, Communication, Knowing and managing yourself and producing results.
Place of assignment
Fiji
Travel
Consultant will need to travel to Fiji in order to undertake this work i.e. if they are based outside of Fiji. Visa processing and related fees are to be carried by the consultant.
Medical clearance
The consultant will be expected to provide a medical certificate of fitness for work
Payment
Payment will be made in instalments and discussed upon issuing of contract.
Detailed cost and budget breakdown
Please quote your professional fee per day for 20 working days
Applications
Qualified and interested individuals or institutions should submit their application letter, CV with an expected quotation wpfjidpsprocurement@who.int by 17 June 2018. Please use Tender Notice No. 73152 as subject to all submissions.
Only short-listed applicants will be contacted.
UNSPSC:
J - Services
85000000 - Healthcare Services
85100000 - Comprehensive health services
85101700 - Health administration services
85101702 - Health legislation or regulations
85120000 - Medical practice
85121500 - Primary care practitioner services
85121504 - Primary care physician emergency medical services
85121600 - Medical doctor specialist services
There have been no revisions to this notice.
NOTE: Multiple Countries (Total: 84)
Type of notice :Request for EOI
More Details :J - Services
85000000 - Healthcare Services
85100000 - Comprehensive health services
85101700 - Health administration services
85101702 - Health legislation or regulations
85120000 - Medical practice
85121500 - Primary care practitioner services
85121504 - Primary care physician emergency medical services
85121600 - Medical doctor specialist services
Documents
Tender Notice