Expert Committee on Specifications for Pharmaceutical Preparations
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(...) Events
25 April – 2 May 2022
56th Expert Committee on Specifications for Pharmaceutical Preparations
WHO Technical Report Series
The WHO Expert Committee on Specifications for Pharmaceutical Preparations meets annually and their reports (WHO Technical Report Series) include all the adopted guidelines in the form of annexes.
(...) WHO Technical Report Series 1033
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Previous reports
21 April 2020
WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fourth report
WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fourth report
1 June 2019
TRS 1019 - 53rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 1019 - 53rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
16 May 2018
TRS 1001 - 52nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 1001 - 52nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
14 June 2017
TRS 1003 - 51st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 1003 - 51st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 2016
50th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 996
50th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 996
21 May 2015
49th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 992
49th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 992
1 June 2014
48th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 986
48th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 986
1 May 2013
47th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 981
47th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 981
1 June 2012
46th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 970
46th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 970
13 April 2011
Forty-fifth report of the WHO Expert Committee on specifications for pharmaceutical preparations
Forty-fifth report of the WHO Expert Committee on specifications for pharmaceutical preparations
1 June 2010
44th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 957
44th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 957
1 June 2009
43rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 953
43rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 953
1 June 2008
TRS 948 - 42nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 948 - 42nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 2007
TRS 943 - 41st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 943 - 41st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 2005
TRS 929 - 39th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 929 - 39th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 2004
TRS 917- 38th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 917- 38th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 2003
TRS 908 - 37th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 908 - 37th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 2002
TRS 902 - 36th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 902 - 36th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1999
TRS 885 - 35th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 885 - 35th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1996
TRS 863 - 34th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 863 - 34th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1993
TRS 834 - 33rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 834 - 33rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1992
TRS 823 - 32nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 823 - 32nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1990
31st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 790
31st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 790
1 June 1987
TRS 748 - 30th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 748 - 30th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1984
TRS 704 - 29th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 704 - 29th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1982
28th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 681
28th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 681
1 June 1980
27th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 645
27th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 645
1 June 1977
26th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 614
26th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 614
1 June 1975
25th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 567
25th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 567
1 June 1972
TRS 487 - 24th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
TRS 487 - 24th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
1 June 1971
23rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 463
23rd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 463
1 June 1969
22nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 418
22nd report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 418
1 June 1965
21st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 307
21st report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations - TRS, No. 307
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© 2022
WHO
Language:English
Score: 1086003.1
-
https://www.who.int/teams/heal...or-pharmaceutical-preparations
Data Source: un
A Prakas (Proclamation) of the Ministry of Health shall determine:
the formalities and conditions to apply for authorization to open, close or change of location of pharmacies, pharmaceutical manufacturing establishments, or companies involved in importing and exporting pharmaceuticals,
the formalities and conditions for application for a visa on the pharmaceutical log- book,
the formalities and technical conditions for the management and preservation of pharmaceuticals,
the formalities and conditions for advertising of pharmaceuticals, and
procedures for the production, import, export and trade of pharmaceuticals.
(...) Authorization from the Ministry of Health shall be required for:
the opening, closing or changing of location of pharmacies, companies involved in importing and exporting pharmaceuticals or pharmaceutical manufacturing establishments.
businesses involved in importing and exporting pharmaceuticals,
importation, exportation and storage of pharmaceuticals and raw materials for the production of pharmaceuticals,
advertisement of pharmaceuticals.
2. (...) CHAPTER V: PENALTIES
ARTICLE 10: Shall be penalized to a fine from 1,000,000 (one million) to 10,000,000 (ten million) riels and to a suspension of (activity) production or import, export or trade of pharmaceuticals for a period from one (1) month to three (3) months, or to either one of the above two punishment terms, exclusive of punishment for other offenses, for any person who:
1. advertised pharmaceuticals without authorization from the Ministry of Health.
2. who violated procedures and conditions for the production, import, export and
trade of pharmaceuticals.
3. opened or changed locations of pharmacies, conducted businesses involved in
importing and exporting pharmaceuticals or manufactured pharmaceuticals without proper authorization from the Ministry of Health.
4. produced, imported, exported or stored pharmaceuticals or pharmaceutical raw
materials without proper authorization from the Ministry of Health.
5. sold pharmaceuticals without approval or keeping a log-book or sold those
pharmaceuticals which are prohibited by the Ministry of Health.
Language:English
Score: 1083554.6
-
https://www.wto.org/english/th...e/khm_e/WTACCKHM3A3_LEG_38.pdf
Data Source: un
24mccollough_e
WHO-WTO Workshop Presentation Oslo
by Keith McCullough
VUNA HEALTHCARE LOGISTICS A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
Session V – Market Segmentation: Techniques,Actors & Incentives
PURCHASE UNDERTAKINGS
Including security and prevention of diversion
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
Business focus
Pharmaceutical & Healthcare
support services
Consultancy Planning – Strategic and Operational Implementation – Turn key Process Management
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
COMED – Price Differentials
Central Tendering Commission for Pharmaceutical and Surgical products and other medical requisites
Two Markets – Public & Pvt
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
PHARMACEUTICAL/SURGICAL STOCK
HOSPITAL Data PHARMACY,WARDS,OT’S
PATIENT Care
PREPACK Demand
PHARMACY STORECLINIC Data
PROVINCIAL DEPOT/s
& sub-depots
MANUFACTURER JIT
IDEAL STOCK LEVELS
Supply Chain Mananagement from Supplier to Patient
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
Main areas of competency & activity
Patient clinical & pharmaceutical management systems
Clinic management systems
Hospital management systems
Pharmacy management
Procurement & logistics
Distribution: direct and different carriers
Depot management: physical and virtual
Repacking unit set-up and management
Training for all operational activities
Health Facility design
Financial management
Management information reports and analysis
Broad hands-on management expertise
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
Final Security
BATCH NUMBER and any other distinguishing
mark or electronic identifier
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
Wards,Theatres and Clinics
Culture
Threat
Attitude
Resource
Problem Areas to be Addressed MAT
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
MAT & Diversion - Answer
lSystems bases on Batch Number and Expiry Date lIntegrated Systems at Different Levels of the Supply Chain lRisk Management and Process Control Management
VUNA HEALTHCARE LOGISTICS
A THEBE COMPANY
PHARMACEUTICAL AND HEALTHCARE SUPPORT SERVICES
Thank YouThank YouThank YouThank YouThank YouThank YouThank YouThank You
Language:English
Score: 1067784.2
-
https://www.wto.org/english/tr...entations_e/24mccollough_e.pdf
Data Source: un
The theme for this year's deliberations was "Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry". Several important issues for the progress of the Indian pharmaceutical industry were deliberated, including critical verticals to foster access to pharmaceuticals at national and international level, promoting production and technology adoption in pharmaceutical enterprises for meeting national and global public health needs, regulatory issues and challenges for medical devices and diagnostics.
(...) The Department of Pharmaceuticals (DOP) plans to launch 1000 Jan Aushadi stores in the country this year. (...) Senior officials including Dr VK Subburaj, Secretary, Department of Pharmaceuticals; Mr Sudhansh Pant, Joint Secretary, Department of Pharmaceuticals; Dr M Ariz Ahammed, Joint Secretary, Department of Pharmaceuticals; Dr Habil Khorakiwala, Chairman FICCI Life Sciences Council, Past President FICCI and Chairman Wockhardt Group; Mr.
Language:English
Score: 1067317.3
-
https://www.who.int/india/news...th-india-pharma-summit-2014-15
Data Source: un
In addition, FIP and The Royal Pharmaceutical Society (GB) have agreed to launch a Global Pharmacy Workforce Observatory in 2014, that will contain all relevant data collected concerning the pharmaceutical workforce.
2. (...) Accessibility
- Distribution of pharmaceutical HRH training insititutions by geographical location. - Distribution of pharmaceutical HRH by geographical location. - Density of pharmaceutical HRH for rural areas / density of HRH for urban areas in countries.
Availability
- Total number of pharmaceutical HRH (and density per 1,000 population). - Number of pharmaceutical students graduating each year. - Proportion of pharmaceutical students that are nationals.
Language:English
Score: 1067058
-
https://www.who.int/workforcea...alPharmaceuticalFederation.pdf
Data Source: un
In fact, there are many
different ways to exploit the right to use the
pharmaceutical invention. The main ways of using a
pharmaceutical invention are manufacturing
pharmaceuticals: application of a patented process for
manufacturing a pharmaceutical product; exploiting the
utility of the protected pharmaceuticals or
pharmaceuticals produced under the protected process;
10 ibid art 62.
(...) Accordingly, the act of
infringement of rights to pharmaceutical inventions are
the same as rights to pharmaceutical invention within its
protection term. (...) STATUS OF PROTECTION OF IP RIGHTS FOR
PHARMACEUTICAL INVENTIONS IN VIETNAM
A. REGISTRATION AND GRANT OF PROTECTION FOR
PHARMACEUTICAL INVENTIONS
As mentioned above, a pharmaceutical invention is
always considered protected under Vietnamese law.
Language:English
Score: 1065841.2
-
https://www.wto.org/english/tr...s_e/2018/chapter_16_2018_e.pdf
Data Source: un
As a result of the 1994 Agreement and the subsequent reviews, participating members committed to eliminate customs duties and all other duties and charges not only on all finished pharmaceutical products, whether sold in bulk or in dosified packages for retail sale (paracetamol, antibiotics, vaccines, etc.), but also on over 7,000 pharmaceutical active ingredients and chemical components used in pharmaceutical supply chains. An indicative list of covered items is contained in JOB/MA/142 .
Trade in pharmaceutical products
International trade in pharmaceutical products has experienced dynamic growth since the adoption of the Pharma Agreement. (...) Trade in pharmaceutical active ingredients and chemical components has also grown steadily.
Language:English
Score: 1062596.4
-
https://www.wto.org/english/tr...ma_ag_e/pharma_agreement_e.htm
Data Source: un
EITHER: [Name of Member] has no manufacturing capacities in the pharmaceutical sector. [Information on how this was established.]
OR: [Name of Member] has found that its manufacturing capacity in the pharmaceutical sector is insufficient to meet its needs for this (or these) pharmaceutical product(s). (...) OPTIONAL, IF NO PATENTS IN FORCE: [The pharmaceutical product(s) is (are) not protected by patent in the territory of [name of Member]].
Language:English
Score: 1060091.4
-
https://www.wto.org/english/tr...31bis_model2notes_notifs_e.doc
Data Source: un
EITHER: [Name of Member] has no manufacturing capacities in the pharmaceutical sector. [Information on how this was established.]
OR: [Name of Member] has found that its manufacturing capacity in the pharmaceutical sector is
insufficient to meet its needs for this (or these) pharmaceutical product(s). (...) OPTIONAL, IF NO PATENTS IN FORCE: [The pharmaceutical product(s) is (are) not protected by patent in the territory of [name of Member]].
Language:English
Score: 1060091.4
-
https://www.wto.org/english/tr...31bis_model2notes_notifs_e.pdf
Data Source: un
LTD 24 months + 24 months + 12 months renewable
RFP-DAN-2021-503305 07/06/2021 Pharmaceuticals in Category 8 (Anaesthetics, Analgesics, Antidotes, Mental Health medicines)
Time Bound LTA Mepro Pharmaceuticals Pvt Ltd 24 months + 24 months +12 months renewable
RFP-DAN-2021-503305 07/06/2021 Pharmaceuticals in Category 8 (Anaesthetics, Analgesics, Antidotes, Mental Health medicines)
Time Bound LTA Reyoung Pharmaceutical Co Ltd 24 months + 24 months + 12 months renewable
RFP-DAN-2021-503305 07/06/2021 Pharmaceuticals in Category 8 (Anaesthetics, Analgesics, Antidotes, Mental Health medicines)
Time Bound LTA Fresenius Kabi 24 months + 24 months + 12 months
RFP-DAN-2021-503305 07/06/2021 Pharmaceuticals in Category 8 (Anaesthetics, Analgesics, Antidotes, Mental Health medicines)
Time Bound LTA Morningside Pharmaceuticals Ltd. 24 months + 24 months +12 months renewable
RFP-DAN-2021-503305 07/06/2021 Pharmaceuticals in Category 8 (Anaesthetics, Analgesics, Antidotes, Mental Health medicines)
Time Bound LTA G.L. Pharma GmbH 24 months + 24 months + 12 months renewable
RFP-DAN-2021-503305 07/06/2021 Pharmaceuticals in Category 8 (Anaesthetics, Analgesics, Antidotes, Mental Health medicines)
Time Bound LTA SM Pharmaceuticals SDN. (...) Extension 24 months DAN-2019-RFP 503000 24/06/2019 Anti-infective pharmaceuticals category 2 - Extension Time Bound LTA Mepro Pharmaceuticals Pvt Ltd Extension 24 months DAN-2019-RFP 503000 24/06/2019 Anti-infective pharmaceuticals category 2 - Extension Time Bound LTA Macleods Pharmaceuticals Limited Extension 24 months
DAN-2019-RFP 503000 24/06/2019 Anti-infective pharmaceuticals category 2 - Extension Time Bound LTA MILAN LABORATORIES (INDIA) PVT.
Language:English
Score: 1059924
-
https://www.unicef.org/supply/...contract-awards-april-2022.pdf
Data Source: un