The UAE Ministry of Health announces conditions and procedures for licensing medical products factories
The Ministry of Health and Community Protection issued Resolution 88 of 2023 regarding the conditions and procedures necessary for licensing to open a factory for medical products. It asked factories that obtained initial approval or a license to open a factory on the date of this decision, to adjust their conditions within 6 months of the date of this decision, and these factories are excluded from the conditions that apply only to Licence applicants to open a factory for the first time.
The Ministry of Construction and Infrastructure has defined general conditions for the formation of factories, one of which is that the factory must be created and constructed in the industrial zones of the country according to the classification of the competent official authorities in each emirate. In order to begin the process of constructing the factory, it is obligatory to take into consideration the technical criteria for establishing buildings for medical product factories that are founded on the principles of good manufacturing practise.
One of the requirements is that the floor space of the facility must be appropriate for the nature of the goods being manufactured, as well as the type and size of the production lines. The layout takes into account how easy it is to move people and materials, how to prevent contamination and the mixing of materials, how to provide the essential equipment and tools, and how to make the manufacturing processes as easy as possible while maintaining a logical order. The structure that houses the manufacturing needs to be situated in an area that is not difficult to reach. The location is required to have all of the essential services available, including running water, power, adequate ventilation, and other amenities.
Stages of factory licensing
The Ministry has designated three steps for the licencing of the factory, the first of which is the approval to begin construction on the factory building, followed by the final approval and the issue of the licence. These stages are represented by the receipt of the application and the initial approval by the appropriate department within the Ministry.
It has been confirmed by the Ministry that a technical team has been assembled in the appropriate department of the Ministry in order to investigate the application, examine its contents, and determine whether or not it satisfies the necessary papers and requirements. free of charge), to issue a licence for industrial use.
The provision of a copy of all agreements with the foreign company (if any) is one of the most important documents that need to be provided in order to finish the licencing process. Another important document is a copy of the report on the non-exposure of the environment to pollution as a result of production operations in the factory. This report must be issued by the authority that is competent in this regard or the concerned section of the Free Zone Authority or another section. Control of the environment and public health are responsibilities that fall under the purview of the municipality department of the emirate in which the factory building is situated. It is necessary to offer not only a list of the forms or kinds of medical products that are to be manufactured but also the number of production lines that are required for each type of medical product (and the pharmaceutical form, in the case of the manufacturing of pharmaceutical products). In addition, it is necessary to state the number of packing lines that are needed for each and every product. In order for this to be established, and in the event that sterile medical items are to be produced, the type of sterilisation that is going to be followed must be indicated.
The Ministry has stated that if all of the prerequisites and conditions are satisfied, an official letter will be issued permitting the construction of the factory buildings and equipping it with machinery, equipment, and devices in accordance with the licences issued by the competent authorities in the country, and the licence applicant must start implementation while adhering to all of the specifications contained in the submitted documents within six months of the date of receipt of the documents. The official letter will be issued if all of the requirements and conditions are met by the applicant. And in the event that there is something that prevents the start of implementation, the licence applicant is required to notify the competent department, stating the reasons for the delay; otherwise, the competent department will take the necessary legal measures towards cancelling the approval that was issued to allow the start of construction of the factory building and its preparation. Moreover, in the event that there is something that prevents the start of implementation, the competent department is required to be notified by the licence applicant, stating the reasons for the delay.
And in accordance with the decision, "in the event that the factory is allowed to produce narcotic drugs and psychotropic substances, the competent department in the ministry has the right to determine the number of basic technical cadres according to the nature, size, and nature of the factory, and the ministry issues a professional licence for the technical director only, and a letter of approval for the directors of the factory's departments and the pharmacist responsible f for the production of the drugs," the number of basic technical cadres will be determined according
In accordance with the decision, the responsible department is to appoint a specialised technical team to investigate the extent to which the rules of good manufacturing are being applied. This is done to ensure that the team reviews and ensures that the requirements are met, through field visits to the site before the certification procedures, and before operating any production plan, in the event that the factory is newly constructed within the country.
In addition, once the process of certification has been completed, the inspection team will travel to the various portions of the plant and its various sections, where they will take notes to confirm that the requirements for the production lines are being met and that they are operating appropriately.
According to the decision made by the minister, medical product factories that are licenced in the country have a number of responsibilities and obligations that must be met in order to complete good manufacturing practises. These duties and obligations include notifying the appropriate division within the ministry officially of the products that are going to be produced along with all of the information related to the qualitative composition, quantity, pharmaceutical form, and quality of medical devices, means and supplies, as well as the products that are going to be produced.
As part of the obligations that have been placed on manufacturers by the Ministry, they are required to notify the Ministry in an official capacity in the event that other manufacturing contracts are finalised. Additionally, manufacturers are required to carry out the activities that the Ministry has granted them permission to practise in accordance with the guidelines for good manufacturing practise and the instructions provided by the Ministry. In addition to this, the licenced manufacturer is obligated to carry out the procedure of conducting the analysis of the finished product within its walls.
The Ministry required that the factory licence be renewed on an annual basis as a condition to verify that the factory is in conformity with good manufacturing practises after an inspection team visited the facility. This condition was imposed when the factory licence was renewed. To renew the certifications of Good Manufacturing Practise that have been issued by the Ministry, an official application must be filed to the Ministry two months in advance of the certificates' expiration date.
The decision made by the ministerial council mandated that factories keep records of narcotic substances, psychotropic substances, and chemical precursors for a period of no less than five years from the date of the last entry of the receipt and delivery data for these substances in the register. This was in addition to the requirement that factories keep documents relating to drug operations for an additional year after the end of each batch.
In the event that the management of the factory desires to make substantial changes, such as the addition of new production lines or main equipment, or changes in the factory plans, or in the event that any of the main technical cadres that have been approved by the Ministry are appointed or changed, the management of the factory is obligated to officially inform the Ministry of these changes. This obligation applies whether the management is in the process of planning to appoint or change these Technical personnel, or after they have actually changed.
It is not permitted to manufacture any medical product without obtaining the approval of the Ministry, and the medical products factory may not import raw materials unless after the approval of the Ministry based on a request submitted to it in accordance with the legislation that is currently in effect. This is one of the most important prohibitions that must be taken into account when operating the factory. The Ministry specified a number of other restrictions that must also be taken into consideration. Factories Possession of drugs and psychotropic substances and products, unless the individual in question is in possession of a permit or permission given by the Ministry in accordance with the terms and processes provided by the law.
The requirement that the process of receiving narcotic substances, psychotropic substances, and chemical precursors be carried out according to a delivery and receipt report in accordance with the controls contained in the legislation that is currently in force in this regard is another one of the prohibitions that have been identified by the Ministry. This requirement is in accordance with the prohibitions that have been identified by the Ministry. It is unlawful to destroy drugs, psychotropic substances, and chemical precursors without the approval of the Ministry, which has given its blessing to this plan after it was reviewed and approved by the appropriate department in the Ministry.