Pharmacy business conditions do not require special control

Article overview

Pharmacy business is not subject to special control and opens up favorable business opportunities for pharmaceutical enterprises. This process simplifies administrative procedures, reduces compliance costs and increases business flexibility. This creates favorable conditions for expanding the drug distribution network, and meeting the growing health care needs of the community. The following article by Long Phan will analyze in detail the legal regulations related to the above content.

Regulations on pharmacy business do not require special control
Regulations on pharmacy business do not require special control

Regulations on drug groups that are not subject to special control

Trading in drugs that are not subject to special control is the trading of drugs that are outside the list of specially controlled drugs. These drugs will not require strict controls in production, circulation and use. This group of drugs typically includes generic drugs, over-the-counter (OTC) drugs, and drugs that are not narcotic, psychotropic, or prone to abuse.

Pursuant to Clause 26, Article 2 of the Law on Pharmacy 2016, the list of drugs not subject to special control includes all drugs that do not belong to the following groups:

  • Addictive drugs.
  • Psychotropic drugs.
  • Precursor drugs.
  • Combination drugs contain addictive pharmaceutical ingredients.
  • Combination drugs containing psychotropic substances.
  • Combination medications contain precursors.
  • Radioactive drugs.
  • Poisonous drugs, toxic medicinal ingredients.
  • Medicines and pharmaceutical substances are on the list of substances banned from use in some specific industries and fields.

This classification helps businesses easily determine their business scope and comply with legal regulations. At the same time, it also creates conditions for state management agencies to effectively supervise and manage the pharmaceutical market.

Pharmacy business conditions are not subject to special control according to regulations

According to the provisions of Article 33 of the Law on Pharmacy 2016, in order to operate a pharmacy without special control, the business establishment must meet the following conditions:

  • Have a Certificate of eligibility for pharmaceutical business issued by a competent authority;
  • Fully meet the conditions of facilities, techniques and personnel specified in Clause 1, Article 33 of the Law on Pharmacy 2016;
  • The person responsible for pharmacy expertise and the person in charge of quality assurance must have a pharmacy practice certificate appropriate to the business establishment.

Fully meeting these conditions not only ensures legal compliance but also contributes to improving service quality, protecting consumer rights and enhancing business reputation in the market.

Requirements for pharmacy business are not subject to special control
Requirements for pharmacy business are not subject to special control

Procedures for applying for a Certificate of eligibility for pharmaceutical business for pharmacy business establishments that are not subject to special control

Documents need to be prepared

Preparing complete and accurate documents according to regulations will help the approval process take place quickly and smoothly. Enterprises need to pay special attention to the legality and updating of documents in records.

Pursuant to Article 38 of the Law on Pharmacy 2016. Application dossier for issuance of Certificate of eligibility for pharmaceutical business includes:

  • Application for issuance of Certificate of eligibility for pharmaceutical business is specified in Form No. 19, Appendix I, Decree 54/2017/ND-CP (amended according to Appendix II, Decree 155/2018/ND-CP);
  • Technical documents corresponding to pharmaceutical business establishments specified in Clause 2, Article 32 of the Law on Pharmacy 2016;
  • A certified copy of the Business Registration Certificate or legal documents proving the establishment of the establishment;
  • Certified copy of Pharmacy Practice Certificate.

Implementation procedures

Pursuant to Article 39 of the Law on Pharmacy 2016, the process for granting a Certificate of eligibility for pharmaceutical business is carried out as follows:

Step 1: The business establishment submits an application for a Certificate of eligibility for pharmaceutical business to the competent authority as prescribed in Article 37 of the Law on Pharmacy 2016. Accordingly, the competent authority includes the following agencies:

  • Minister of Health: for pharmaceutical business establishments specified in Points a, b, c, e, g and h, Clause 2, Article 32.
  • Director of the Department of Health: for pharmaceutical business establishments specified in Points d and đ, Clause 2, Article 32.

Step 2: The competent authority evaluates the dossier and issues the Certificate:

  • Within 30 days from the date of receipt of the complete application dossier, the Minister of Health or Director of the Department of Health shall organize the evaluation and issue the Certificate of eligibility for pharmaceutical business according to authority;
  • In case of refusal, the competent authority must respond in writing and clearly state the reason.

This process ensures transparency and efficiency in pharmaceutical business licensing, creating favorable conditions for businesses in their operation and development.

In-depth consulting services on pharmacy business conditions in accordance with regulations at Long Phan

The pharmacy business does not require special control, opening up potential opportunities for pharmaceutical businesses. At Long Phan, we provide in-depth consulting services, helping customers optimize business processes and fully comply with legal regulations. Using Long Phan’s services, customers will save time, minimize legal risks and increase business efficiency.

Long Phan’s consulting services include:

  • Consulting and evaluating the current situation of the business establishment to meet business conditions.
  • Consulting on necessary facilities and equipment.
  • Support in preparing documents to apply for a Certificate of eligibility for pharmaceutical business.
  • Consulting on pharmacy operating procedures according to regulations.
  • Representatives of establishments/enterprises submit documents and work with competent authorities.
  • Closely monitor the progress of processing documents and have solutions when problems arise.
  • Receive results and deliver them to customers.
Consulting and support at Long Phan
Consulting and support at Long Phan

The pharmacy business does not require special control, opening up great development opportunities for pharmaceutical businesses. To ensure effective business operations and legal compliance, customers need to thoroughly understand the relevant regulations and conditions. Long Phan is ready to support customers in this process. Please contact Long Phan immediately via the hotline 0906735386 to receive in-depth advice and optimal solutions for your business.