Pharmacy Enforcement Branch Pharmacy Enforcement Branch

The Pharmacy Enforcement Branch plays a role in enforcing the act (law) that involves medicine, pharmaceutical products, cosmetics products as well as advertisement of medicine and medical services. This is to ensure the safety and well being of the consumer is protected.

One of the strategies used to reduce the demands of unregistered products is through protection/education. One of the major campaign known as Know Your Medicine.

Apart from the above activities, this branch also focuses to curb activities that are involved in the sales of healthcare and cosmetic product that are unregistered or adulterated with control schedule drugs under the poison list which is harmful to the consumer.

The main activities carried out by The Pharmacy Enforcement Branch include:

  1. Licensing
  2. Intelligence & Operation
  3. Legislation
  4. Advertisement Control
  5. Pharmaceutical Control & Consumer Protection

     

1. Licensing Section
Under this section there are 3 units:
  • Responsible for processing the License Poison of Types A/B/E, Permit NaOH and Permit Methadone under the Poisons Act 1952.
  • Responsible for the inspection activities of licensed premises with CPFKL and also other registered premises such as private hospitals, medical clinics and dental clinics.
  • Inspection of the premises is carried out for the purpose of issuing license to all the pharmacy premises and premises that deals with controlled chemicals for the purpose of industrial use. It is carried out to ensure compliance of each licensee towards poisons license requirements under the Poisons Act 1952.
  • Inspections are also carried out on the registered premises i.e. clinics and private hospitals to ensure that the handling of poisons are according to legal requirements and no sale or supply of scheduled poisons by individuals who are not eligible.

2. Intelligence & Operations Section
Under this section there are 3 units:

  • Intelligence Unit and complaints Unit are responsible for investigating and verify each complaint and information received from the public. Verification of the complaints is to ensure that the person or organization targets, time, location, activity patterns (modus operandi) is accurate. If the information obtained is incomplete, the case will be continued with further strategic intelligence or surveillance.
  • Operations Unit is responsible for raiding activities. Raids will be conducted on various premises. For example, traditional medicines store, drug store, beauty shop, hardware shop, pharmacy, medical clinic as well as residential areas that sell unregistered drugs, sales of poison by individuals who are not licensed as well as cosmetic products that are not notified. Most of the confiscated items are unregistered products mainly sex stimulant drugs that contain Sildenafil and Tadalafil, and slimming pills.

3. Legislation Section
Under this section there are 3 units:

  • The Investigations Unit carry out, consult and monitor activities related to case investigation.
    • Investigation is a process of collecting information relating to the offence committed by the accused up to the stage of prosecution. It involves gathering relevant information from other agencies such as the companies Commission of Malaysia, Department of chemistry, national registration Department, the Malaysian Medical Council, Telekom Malaysia, Kuala Lumpur City Hall (DBKL) and other agencies.
  • The prosecution unit is responsible for coordinating, carrying out, monitoring the activities of the prosecution and also provides consultation for prosecution that include activities relating to application of the law enforced.  
    • Prosecution in court will be conducted once the results of the comprehensive investigation against any individual or company found in breach of the law enforced. Pharmacist appointed as a public prosecutor is responsible for bringing the case to court for prosecution.
  • Handling of exhibits Unit is responsible for coordinating, carrying out and monitoring the activities associated with exhibit. This unit is also responsible to manage and ensure that the activities in the exhibition store is in accordance to the guidelines given.
    • Every seized items is handled and stored properly. The exhibit is wrapped, labelled and stored in the store exhibit. All movement in the store is recorded. This is to ensure that the chain of evidence is not broken.

4. Advertisement Control Section
Under this section there are 3 units:

  • Advertisement Screening Coordination Unit is responsible for coordinating the investigation of advertisement that violate the Medicine Act (Advertisement and Sale) 1956
  • Advertisement engagement unit is responsible for coordinating the screening and monitoring of advertisements in the media and in the premises.
  • Pharmacy Enforcement Developments unit carry out coordination and data analysis of the enforcement pharmacy, research and innovation activities and resources monitoring (financial, staffing and training).

5. Pharmaceutical Control and Consumer Protection Section
Under this section there are 4 units:

  • The objectives of consumer protection Unit is to reduce the sale of unregistered products and cosmetics that are not notified. Thus, a variety of awareness activities such as exhibitions, lectures and dialogues are carried out to increase the level of knowledge regarding products registration. This will help to ensure products in the market are safe, of high quality and effective for use.
  • Pharmaceutical Forensic Unit is responsible for the Pharmaceutical product surveillance by sending a sample of the suspected product for analysis.
  • Pharmaceutical Cyber unit plays a role in monitoring electronic information to ensure that the information published is accurate, correct and true.  
  • Unlicensed Inspection Unit is responsible for coordinating inspection activities, to ensure that the products sold in the market are safe to use.

Date Update: : 14 July 2016

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