Draft law amending and supplementing certain provisions of the Law on Pharmacy – Remarkable points for pharmaceutical enterprises

After more than six years of implementation, the Law on Pharmacy 2016 has effectively overcome the shortcomings of its predecessor, the Law on Pharmacy 2005, and established an important legal framework that improves and enhances the effectiveness of state regulation in the pharmaceutical industry. However, in addition to the results achieved, certain provisions of the current Pharmacy Law 2016 have been identified as no longer practical or suitable for application. The outbreak of the COVID-19 pandemic has created extremely complex and unpredictable situations, resulting in significant changes in the socio-economic management landscape, particularly in relation to drug supply operations. The current regulations, which are still cumbersome, have posed particular challenges for importers and suppliers of medicines when implemented in urgent cases such as a pandemic. As a result, it is difficult for people to have timely access to quality and effective medicines for disease prevention and treatment.

For this reason, the Ministry of Health has prepared a draft law to amend and supplement certain provisions of the Law on Pharmacy with specific content aimed at addressing the aforementioned limitations. Currently, this draft is still in the process of gathering feedback in order to finalize it and submit it to the National Assembly. In this article, HM&P will highlight some adjustments in the draft that companies will need to consider in their operations.

1. Considerations related to drug registration dossiers in urgent situations to meet critical needs

In accordance with the current regulations, the dossier for the registration of a medicinal product consists of administrative and technical documents, including clinical records. Subsequently, the Minister of Health will issue a certificate of free sale based on the evaluation of the dossier and the advice of the Advisory Council[1].

Administrative records for imported drugs require a Certificate of Pharmaceutical Product (CPP)[2]. The CPP is a certificate issued in the format recommended by the World Health Organization (WHO) in accordance with WHO’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce[3].

According to Point b Clause 2 Article 56 of the Law on Pharmacy 2016, regarding to the technical records, it is required that new drugs, reference biological products, vaccines, and medicinal materials indicated for diseases listed by the Minister of Health must provide additional clinical documents proving their safety and efficacy.

In practice, during the recent Covid-19 pandemic, out of the 10 vaccine certificates of free sale received by the Ministry of Health, only 2 were able to provide the Certificate of Pharmaceutical Product. The remaining applicants could only provide alternative documents to demonstrate legal sale[4]. In addition, under the current regulations, even if new drugs for disease treatment have been evaluated by the Stringent Regulatory Authorities (“SRA”)[5], they still need to be evaluated by the Advisory Council for certification when applying for distribution in Vietnam. This requirement has a significant impact on the population's timely access to essential medicines for disease treatment.

As a result, the upcoming revision of the Law on Pharmacy has included additional provisions to address urgent needs in national defense, security, disease prevention, control, post-disaster recovery and humanitarian relief efforts. The Certificate of Pharmaceutical Product may be replaced by legal documents confirming the authorized free sale of medicines. In addition, in cases where it is necessary to meet the above-mentioned urgent needs:

• For new drugs produced domestically with the same active ingredient, pharmaceutical form, and route of administration as a previously approved free sale drugs by one of the regulatory agencies listed in the SRA, when submitting an application for circulation registration, they may be exempted from providing clinical trial data[6];
• For new drugs used in epidemic prevention and control, which are manufactured abroad and have been granted circulation authorization by listed in the SRA, when applying for free sale registration in Vietnam, they may be issued a certificate based on the recognition of the free sale authorization granted by listed in the SRA, without having to evaluate compliance with GMP requirements or review the technical dossier (quality, preclinical, clinical) within the drug registration dossier[7].

Therefore, this regulation has overcome the lack of flexibility in the current strict drug registration process, which is primarily suitable for normal circumstances. In urgent situations, alongside ensuring quality control, the primary objective remains to provide rapid public access to drugs and vaccines that meet the standards and safety measures required for effective treatment.

2. Considerations related to the process and procedures for extension, modification, and supplementation of certificates of drug circulation registration

2.1 Streamlining the procedure for certificates of drug circulation registration

If enterprises wish to extend their drug circulation registration certificates, they are required to start the extension process. The application for extension will be evaluated and deliberated by the Advisory Council, and the Minister of Health will make a decision[8].

This regulation has shown its limitations when during the drug renewal process, there are no technical content changes during the drug renewal process, only administrative changes. However, enterprises are still required to submit extensive documentation[9]. In addition, the dossier includes numerous reports related to the distribution, resulting in a significant amount of paperwork to be collected. As a result, the evaluation period is prolonged, leading to disruptions in the distribution, production and supply of medicines on the market due to expired or pending registration certificates. Simplifying these procedures is therefore essential to avoid wasting time, costing companies money, and burdening government administrative resources.

In order to facilitate the implementation of the automatic renewal of certificates of drug circulation registration in accordance with the guidelines set out in the Prime Minister's Decision 1661/QD-TTg dated October 4, 2021, the Ministry of Health has made significant adjustments to the proposed amendment to the Law on Pharmacy, particularly with regard to the documentation requirements and procedures for the renewal of certificates of drug circulation registration. 

Accordingly, companies that need to extend their certificates of registration for the distribution of medicinal products need only submit an application for the extension of certificates of registration for the distribution of medicinal products, which must include the following minimum information:

• Information on the manufacturer’s GMP certificate
• Legal documents of the manufacture
• Information on drugs still in circulation in the host country
• Commitment to fulfilling the responsibility of monitoring the quality, safety, and effectiveness of drugs in accordance with the regulations stated in Point a Clause 5 Article 77 of the Law on Pharmacy 2016 and not falling under any of the cases requiring withdrawal of the certificate of drug circulation registration as specified in Clause 1 Article 58 of the Law on Pharmacy 2016[10].

It is clear that the simplification of this procedure demonstrates Vietnam's significant progress in administrative management, saving time and money for both enterprises and the government, and creating favorable conditions for efficient business operations for suppliers.

In addition, due to the flexible transition of the initial assessment process to both circulation and post-audit, enterprises should also take note of the fact that this extension mechanism will involve maintenance fees as stipulated by the Ministry of Finance[11].

2.2 Not all cases of change or supplementation of certificates of drug circulation registration must be appraised

In addition to addressing the limitations in the extension procedures and the process of amending or supplementing the certificates of drug circulation registration, the simplification policy is also being considered for implementation.

At present, when companies want to amend or supplement the certificates of drug or drug raw material circulation registration, they have to wait for the dossiers to be reviewed. Meanwhile, the amendment and supplementation of contents in the circulation process of drugs and drug ingredients is a regular thing of enterprises. Therefore, if each period of change and addition has to be reviewed, the period of obtaining approval from the Minister of Health will be long, which will affect the business and production activities of enterprises and limit people's rapid access to improved drugs.

Taking into account the practical situation, the proposed amended regulations provide for additional cases of changes and additions to the certificates of registration of medicinal products in circulation, which can be implemented immediately without approval; cases of approval of changes and additions without the need to go through the review and consultation of the Advisory Council. These cases will be specified by the Minister of Health. Thus, the draft has set a positive limit that not all cases of changes and additions to certificates of registration of circulation of medicinal products or medicinal raw materials must fully comply with the process of dossier evaluation and consultation of the Advisory Council. This will help to reduce the workload of the Advisory Council, avoid waste of resources and focus only on the statutory cases that need to be evaluated and consulted.  

It can be seen that these changes are due to shortcomings in the import, manufacture and registration for distribution of drugs and medicinal herbs in the past Covid-19 period that the Law on Pharmacy 2016 could not be fully anticipated at the time of promulgation. Overall, these changes can be seen as positive for the people and pharmaceutical companies in Vietnam. The simplification of procedures saves resources and money, saves human resources, promotes economic circulation activities, and makes social management more effective.

According to the Ministry of Health's Plan No. 1015/KH-BYT dated July 26, 2023, the draft law amending and supplementing certain provisions of the Law on Pharmacy is expected to be submitted to the National Assembly for comments at the 7th session (May 2024) and approved at the 8th session (October 2024). Therefore, companies need to be aware of the latest regulations and updates soon to be prepared for their operations.