4.OHS and Legislation in The Industry

4.
OHS and Legislation in the Industry
Hazard is a term associated with a substance that is likely to cause an injury in a given
environment or situation. Industrial hazards are a major occupational health and safety (OHS)
issue in pharmaceutical manufacturing. In recent years chemical safety and the sound
management of chemicals have seen great progress at the global level. At the same time, the
rapid growth in production and dissemination of both natural and synthetic chemicals has led
to concern about their impact on the natural environment, and human health. In this way, the
pharmaceutical industry has come to occupy a unique position. Practically no other
commercial enterprises present such a wide variety of potentially toxic exposures or such a
rapidly changing advent of new chemical substances [1].
4.1 Why OHS is Important in the Pharmaceutical Industry
 To protect colleagues and customers

 To seek new ways of improving health and safety
 Ensures staff learn from any investigations.
4.2 Legislations in the Pharmaceutical Industry
Pharmaceutical manufacturing exposes workers to a variety of unique hazards, ranging from

hazardous biological pathogens, poisonous fumes, and flammable materials. The risks
associated with these health hazards can be minimized by ensuring that workers have proper
PPE that provides a protective barrier to skin, eyes, mucous membranes, hair, and clothing.
Of course, appropriate PPE is just one piece of the puzzle when it comes to preventing
workplace injury within this important industry. Employers should consult with local and
national regulatory agencies to ensure they remain in compliance with all relevant safety
standards [2].
4.3 EU Pharmaceutical Legislations
In April 2023, the European Commission (EC) published its proposals, the first major
overhaul to the EU’s medicines regulations in 20 years, to revise the following EU
pharmaceuticals legislation [3]:
 Regulation 726/2004 - authorization and supervision of medicinal products for human

use and establishing a European Medicines Agency (EMA).
 Regulation 141/2000 on Orphan Medicinal Products (OMPs) laying down criteria for
designating certain medicinal products as orphan drugs.
 Regulation 1901/2006 on medicinal products for pediatric use.
 Regulation 1394/2007 on Advanced Therapy Medicinal Products (ATMPs).
 Regulation 536/2014 on clinical trials on medicinal products for human use.
 Directive 2001/83 on the Union code relating to medicinal products for human use.
The EC’s legislative proposal has an overarching goal of so-called ‘3 As’ - Affordability,
Accessibility, Availability - and it includes, amongst others, the following objectives:
 Putting patients in the center - equal access and security of supply for patients across
the EU.
 Driving innovation for the pharmaceutical industry through a number of incentives

related to market exclusivity.
 Developing the criterion-based definition of unmet medical need (UMN) and scientific
guidelines on the category of ‘orphan medicinal products’ addressing high unmet
medical need (HUMN).
 Introducing structural changes to the European Medicines Agency (EMA), which

includes greater representation of patients and healthcare professionals.
 Adopting a list of critical medicines that require coordinated EU-level action to

prevent medicines shortages.
 Repurposing off-patent medicines.
 Greater transparency in public funding for research and development of medicines.

4.4 Pharmaceutical Legislations in Türkiye
The Regulation on Pharmaceutical Establishments and Products in Pharmaceutical

Establishments (“Regulation”), drafted by the Turkish Pharmaceuticals and Medical Devices
Agency (“Agency”), was published in Official Gazette dated 15 June 2022 and numbered
31867 and entered into force on the same date.
The regulation harmonizes the rules regarding the supply chain of products and active
substances in pharmaceutical establishments with the European Union regulations [4]. The
Regulation may be summarized as below:
 It is mandatory for the product and active substances to follow the legal supply chain.
The legal supply chain consists of persons, institutions, and organizations that have
been authorized within the framework of the relevant legislation and carry out relevant
activities according to the relevance of the products and active substances.
 The export of pharmaceuticals may be carried out in accordance with the relevant
country legislation, without prejudice to the provisions of the relevant legislation and
by making the Pharmaceutical Track and Trace System notifications.
 Products that are detected or suspected to be unlicensed/unauthorized, counterfeit,

incorrectly manufactured, modified and/or corrupted shall be notified to the Agency
and the license holder. The Agency may take measures to prevent the related products
from entering the supply chain.
 Natural or legal persons or persons who want to operate transfer centers shall apply to
Provincial and District Health Directorates for opening.
 Detailed regulations have been made on brokerage, inspection, and sanctions.
 Pharmaceutical establishments, for which a license was issued before the Regulation
came into force, are obliged to bring their permits into compliance with the Regulation
within 18 months from the date of publication of the Regulation.
References
[1] Khanna, S., Kumari, G., Bhanawat, H., & Pandey, K. M. Occupational Health
and Safety of Workers in Pharmaceutical Industries.
[2] Pharmaceutical PPE and Safety Protocols for your company. International
Enviroguard. (n.d.). https://int-enviroguard.com/blog/5-top-safety-risks-in-
pharmaceutical-manufacturing/
[3] ESMO. (2023, September 11). EU pharmaceuticals legislation. European

Society for Medical Oncology. https://www.esmo.org/policy/eu-pharmaceuticals-
legislation
[4] Arseven, M. (2022, August 24). Turkey Announces the Regulation on

Pharmaceutical Establishments and Products in Pharmaceutical Establishments.
https://www.morogluarseven.com/news-and-publications/turkey-announces-the-
regulation-on-pharmaceutical-establishments-and-products-in-pharmaceutical-
establishments/

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4.

OHS and Legislation in the Industry

4.1 Why OHS is Important in the Pharmaceutical Industry

 To protect colleagues and customers

4.2 Legislations in the Pharmaceutical Industry

Pharmaceutical manufacturing exposes workers to a variety of unique hazards, ranging from

 Regulation 726/2004 - authorization and supervision of medicinal products for human

 Regulation 1901/2006 on medicinal products for pediatric use.

 Regulation 1394/2007 on Advanced Therapy Medicinal Products (ATMPs).

 Regulation 536/2014 on clinical trials on medicinal products for human use.

 Driving innovation for the pharmaceutical industry through a number of incentives

 Introducing structural changes to the European Medicines Agency (EMA), which

 Adopting a list of critical medicines that require coordinated EU-level action to

 Repurposing off-patent medicines.

 Greater transparency in public funding for research and development of medicines.

The Regulation on Pharmaceutical Establishments and Products in Pharmaceutical

 Products that are detected or suspected to be unlicensed/unauthorized, counterfeit,

 Detailed regulations have been made on brokerage, inspection, and sanctions.

[3] ESMO. (2023, September 11). EU pharmaceuticals legislation. European

[4] Arseven, M. (2022, August 24). Turkey Announces the Regulation on

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