Good storage and distribution practices may apply to all
organizations and individuals involved in any aspect of the
storage and distribution of all the drug products. Storage
and distribution may involve the complex movement of
products around the world, differences in documents and
handling requirements and communication among various
entities in the supply chain.
This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...
Good storage and distribution practices may apply to all
organizations and individuals involved in any aspect of the
storage and distribution of all the drug products. Storage
and distribution may involve the complex movement of
products around the world, differences in documents and
handling requirements and communication among various
entities in the supply chain.
This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
Guidelines on the manner of application to Guidelines on the manner of applic...Serkan Kaçar
Guidelines on the manner of application to turkish medicine and medical device agency in clinical trials, published by Turkish Medicine and Medical Device Agency
Guidelines on the collection verification and submission of reports on advers...Serkan Kaçar
Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency
Guidelines for principles and rules for good clinical practices of advanced t...Serkan Kaçar
Guidelines for principles and rules for good clinical practices of advanced therapy medicinal products, published by Turkish Medicine and Medical Device Agency
Guidelines for principals on planning and evaluations of trainings,Guidelines...Serkan Kaçar
Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Guidelines on storage and distribution of investigational products, published by Turkish Medicine and Medical Device Agency
1. GUIDELINES ON STORAGE AND DISTRIBUTION OF INVESTIGATIONAL
PRODUCTS APRIL 2013
1. OBJECTIVE
This guideline has been prepared to provide guidance about storage and distribution of
investigational products to be used in clinical trials under suitable conditions.
2. DEFINITIONS
Definition in the Good Clinical Practice Guideline and in the relevant legislation shall apply.
3. QUALITY SYSTEM AND ASSURANCE
3.1. The institution or organization performing storage operations should establish a suitable quality
system.
3.2. A quality assurance system ensuring that the quality of the investigational products stored at the
warehouse is maintained throughout the shelf-life should be in place.
3.3. The quality assurance system should ensure that at least the following are met with respect
to the investigational products:
3.3.1. The investigational products are used in an approved clinical trial in accordance
with the relevant legislation,
3.3.2. The investigational products are permitted for import in accordance with the
relevant legislation,
3.3.3. Storage conditions including the shipment processes are continuously under
control and are suitable,
3.3.4. The investigational products shall not be subjected to contamination or
crosscontamination with the other products,
3.3.5. An effective emergency action plan is in place,
3.3.6. A system ensuring monitoring to easily identify defective products is in place.
3.4. Written, approved standard operating procedures for all processes and procedures that
may affect the quality and distribution operations of the products such as goods
acceptance and control, storage pest control, shipment, destruction, recording, actions to
be taken for returned goods, precaution systems against natural disasters should be
established.
4. PERSONNEL
4.1. Organization chart of the warehouse should be prepared indicating the key personnel as
well.
4.2. In the warehouse, assigned responsible person has to be graduated from faculty of pharmacy and the
person should have the right to practice their profession in Turkey.
4.3. There should be an authorized quality assurance responsible in charge of implementation
of quality assurance systems who have received adequate and suitable training in the
warehouse.
4.4. All employees should have received training concordant with the duty assigned to them,
and records of such trainings should be maintained. Such trainings should be repeated at
suitable intervals indicated in the standard operating procedures.
4.5. Job descriptions indicating the tasks and responsibilities of all employees should me made
clearly and documented.
4.6. All the personnel processing the investigational products in the warehouse should be
subjected to periodic health control and their records should be maintained. Persons with
infectious diseases or open wounds shall not be appointed to tasks that require a direct
contact with the investigational products.
4.7. The warehouse employees should wear suitable protective or working clothes on or instead
of their usual clothes.
5. BUILDINGS/FACILITIES AND TOOLS/EQUIPMENT
1
2. GUIDELINES ON STORAGE AND DISTRIBUTION OF INVESTIGATIONAL
PRODUCTS APRIL 2013
5.1. The building and equipment should be suitable and adequate to ensure that the
investigational products are properly stored and distributed.
5.2. Necessary measures should be taken against fire and natural disasters and adequate
number of fire-extinguishing tubes and powder should be available.
5.3. Floors, walls and ceilings of the storage area should be water-resistant, easily-cleanable and
of durable material.
5.4. The circumstances stipulated for the storage of the investigational products under suitable
conditions should be monitored with appropriate instruments and devices and all relevant
records should be kept accordingly.
5.5. The storage area should have an administrative division, goods acceptance and shipment
division, storage division, refused goods division, quarantine division as main parts and
other necessary divisions
5.6. The storage area should be designed to have enough space to allow easy acceptance and
shipment processes and ensure the storage and distribution of all investigational products
in the warehouse under suitable and safe manner and conditions.
5.7. The area for receiving and shipping of the goods should be separated from the areas where
the investigational products are stored.
5.8. The investigational products should be protected from bad weather conditions during
loading and unloading processes.
5.9. All instruments and equipment in the warehouse should be in operable conditions.
5.10. All monitoring instruments in the warehouse should be regularly calibrated and the
relevant records should be kept.
6. ACCEPTANCE
6.1. Acceptance area should be separated from storage area.
6.2. Acceptance area should be designed to protect the investigational products from bad
weather conditions during unloading process.
6.3. During acceptance, whether the investigational products have been damaged, the received
goods are the same with the ordered goods and the shelf life should be checked and the
relevant records should be kept.
6.4. The products which require special storage conditions should be immediately identified
during acceptance and stored in accordance with the written standard operating
procedures and the relevant legislation.
7. STORAGE
7.1. The investigational product should be stored under conditions suitable for its quality.
7.2. Temperature and humidity amount of the storage area should be monitored and recorded
electronically 7 days/24 hours in a manner that the data cannot be changed, and the data
should be reviewed regularly. In these systems, there should be a system which gives alarm
when temperatures and humidity amounts are out of the expected values, and
intervention systems should be developed in a manner to protect the quality of the storage
products.
7.3. Temperature distribution map should be generated for the storage area.
7.4. Storage areas should be clean and free from pests. Adequate and effective methods should
be implemented to prevent breaks, spillage, contamination with microorganisms and crosscontamination.
7.5. Persons other than those in charge and who are authorized should not be allowed to enter
the storage areas. Entries and exits should be recorded.
7.6. Investigational products of which the shelf life is expired should be immediately separated
from the available stock, necessary measures should be taken and their distribution should
not be done in any way.
7.7. Necessary measures should be taken for the investigational products which should be
stored under cold chain conditions.
7.8. There should be a quarantine area.
7.9. Places where narcotic, psychotropic products, products containing live microorganisms and
2
3. GUIDELINES ON STORAGE AND DISTRIBUTION OF INVESTIGATIONAL
PRODUCTS APRIL 2013
toxic products should be as a separate section and locked up.
7.10. Instruments or systems that can run on alternative energy resources should be held in
reserve against power outage.
8. SHIPMENT
8.1. The products that are shipped should be secured, and protected from unacceptable levels
of heat, cold, light, moisture or other undesired affects or damages.
8.2. During the shipment of the products subject to cold chain, necessary measures should
absolutely be taken to ensure the products are stored within the specified temperature
ranges.
9. RECORDS
9.1. An emergency plan should be determined in writing. Any practices should be recorded
and records should be kept.
9.2. Any return or rejection processes should be recorded.
9.3. Records should be kept in a manner to monitor all activities and events during each
process.
9.4. The records should be legible, clear and easily accessible when necessary.
9.5. Records kept on computer system should be secured through a backup system and systems
should be validated.
9.6. A self-inspection (auto-control) system should be established, regularly performed and its
records should be kept for control of compliance with the relevant legislation.
9.7. Training records should be kept and regularly performed.
9.8. Destruction processes should be performed in accordance with the relevant legislation and
destruction records should be kept.
10. APPLICATION AND PERMISSION
10.1. The necessary permission is given by Turkish Medicine and Medical Device Agency to institutions
and organizations which have storage and distribution activity of investigational products under appropriate
conditions to be used in clinical trials.
10.2. The institutions or organizations wishing to obtain permission have to submit to Turkish Medicine
and Medical Device Agency with application form from the website of Turkish Medicine and Medical
Device Agency.
10.3. The audit must be carried out within 45 days to the institutions or organizations which have the
appropriate submissions.
11. OTHER PROVISIONS
11.1. This Guideline does not cover labeling activities for investigational products and the required
permissions should be obtained in accordance with the relevant legislation if such activities to be
performed.
11.2. After the granted permission from which Turkish Medicine and Medical Device Agency, the audit
must be performed at least once per year.
12. SUPERSEDED REGULATIONS
The Guideline on Storage and Distribution of Investigational Products Used in Clinical Trials
entered into force upon the Approval dated 23.08.2011 and numbered 7481 has been superseded.
3
4. GUIDELINES ON STORAGE AND DISTRIBUTION OF INVESTIGATIONAL
PRODUCTS APRIL 2013
13. PROVISIONAL ARTICLE
Provisional Article 1:
Activities of the approved instutions and organizations which have storage activity before from the date of
entry into force of this guideline is necessary to make compliance with this guideline in six (6)
months.Institutions and organizations, which in this case will be deemed invalid at the end of the current
approvals for 6 months before the end of this period, so institutions and organizations have to apply again
for approval to Turkish Medicine and Medical Device Agency to operate in warehousing and distribution
activities.
14. ENFORCEMENT
This guideline shall enter into force on the date of approval.
4