Two years since the sector for the galenic laboratory in "Montefarm" has been in existence, that institution has not produced a single drug, and there is no indication of a date for the start of production.
"Montefarm", i.e. the Sector for the Galenic Laboratory, which employs only a female manager, also does not have a single document ready to offer to the Ministry of Health for approval and thereby justify its existence.
In order to start the production of medicines, the galenic laboratory must meet a number of conditions, and submit evidence of this to the Ministry of Health in order to obtain approval for work.
The Ministry of Health told "Vijesta" that "Montefarm" has not yet started the procedure to determine the conditions in terms of equipment, space and personnel, and that one employee - a manager - has been temporarily assigned to the galenic laboratory sector for the time being.
Former Prime Minister Dritan Abazovic in March of this year, he claimed that "Montefarm" can start producing medicines, at least for mass consumption.
"If this is a philosophy that cannot be implemented in Montenegro, then okay, but I believe that it can. I don't believe it, but I am sure that it produces initially less complicated drugs, but which have a large consumption in our health institutions or among citizens, and later, as the company grows, it will specialize in certain drugs," said Abazović at the time.
Created a sector, a complex project
"Montefarm" said that the fourth sector of the galenic laboratory was established two years ago, after 27.12.2021. a decision was made on amending the Rulebook on the systematization of workplaces, which was approved by the Ministry of Health.
They said that an employee, a graduate pharmacist by profession with 37 years of work experience, was assigned to the position of director of the sector, who participated in the preparation of the systematization of workplaces of the future laboratory and the drafting of the Rulebook on the conditions for the production of galenic medicines.
They claim that the employee's task is to prepare that complex project from a pharmaceutical point of view.
"The manager's task, based on her long-term rich work biography, is to prepare the fulfillment of a number of prerequisites before the finalization of this rather complex project, because the idea of reopening the galenic laboratory 'Montefarma' is 7-8 years old. According to the already adopted systematization, the laboratory will have pharmacists with degrees in narrow specialties, pharmaceutical technicians and a certain number of non-medical staff, and only after setting the first production plan and assessing the initial production capacity, providing funds, we will be able to provide more precise answers to the public", claim the institution. at the head of which Goran Marinović.
They pointed out that, as the only state institution engaged in pharmaceutical activity, they are ready to continue preparations for the opening of a galenic laboratory, with the fact that, in addition to professional and technical preparations, it is necessary to provide funds with the support of state authorities.
"Given that Montenegro has had no state reserves of medicines and medical supplies for decades, COVID has additionally shown that complete dependence on imports is problematic for the functioning of the public health system. It was the pandemic that pushed both ideas, both galenic laboratories and drug production, and we believe that an agreement will be reached at the state level and we will start the final implementation for the benefit of the entire society", the answers say.
"Montefarm" says that more than two decades ago, that institution had a galenic laboratory in its composition, which stopped working in the XNUMXs.
They emphasized that Montenegro imports a significant number of galenic preparations, and that they relaunched the same idea about production for several reasons.
"One of them is that among the employees we still have pharmaceutical staff who worked in our galenic laboratory, the second is to maximally reduce the dependence of Montefarm pharmacies on the import of galenic preparations and ultimately create new jobs. Therefore, the benefit would be multiple, that is why the Department of Galenic Laboratories was established, whose first task is to prepare documentation, fulfill a number of prerequisites, perform demand assessments according to reports from our pharmacies, comply with regulations and set an initial production plan", they answered from that institution.
Rulebook adopted, specializations are awarded
When asked what has been done so far in the galenic laboratory sector, "Montefarm" says that in addition to the preparation of extensive documentation, communication was established with the leading pharmacists of the Galena lab Belgrade pharmacy institution and a visit was organized, during which the manager got to know "the galenic laboratory itself, the space that they have, products as well as prerequisites that they had to fulfill before the very opening of this production plant".
"After she was informed in detail and personally convinced of the complexity of the preparatory work, she began to create the Rulebook on the conditions for the production of galenic drugs, the collection of prescriptions for the production of magisterial drugs, where the revision of former prescriptions is currently being carried out, which must be harmonized with modern regulations. Considering that she was convinced of the spatial and production capacities, according to the assessments of the needs of our pharmacies that have been collected so far, and based on the experience of Galena Lab from Belgrade, we started to find adequate space and that process is also ongoing", the answer reads.
"Montefarm" said that after the adoption of amendments to the systematization of workplaces and the institution's Statute, as well as the establishment of the Sector of Galenic Laboratory, which provides for the employment of pharmacists in narrow specialties, they turned to the Ministry with a request for consent to send a certain number of graduated pharmacists to training in order to obtain knowledge, skills and qualifications necessary to work in a galenic laboratory.
"We received a positive response to our request and it will be necessary to announce a competition for the award of specializations. "We still do not have a precise estimate of how long the process will last, given that, as we have already explained, it is necessary to fulfill a number of conditions and, most importantly, to provide staff and funds for the opening of a galenic laboratory," said Montefarma.
The rulebook, adopted at the end of 2021, defines the conditions in terms of space, starting substances, packaging materials, space for temporary accommodation and storage of semi-finished products, space for the production and packaging of galenic drugs, but also for the storage and storage of toxic substances, penicillin antibiotics, cytostatics, sanitary rooms and space for shipping galenic medicines...
In terms of personnel, the Galen laboratory should have at least one graduate pharmacist, a specialist in the field of pharmaceutical technology, that is, a responsible pharmacist with at least three years of work experience in the profession and at least two pharmaceutical technicians with the same years of work experience.
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