With an aim of continuously improving its services and user needs, the Agency for Medicinal Products and Medical Devices (HALMED) conducts an annual survey on satisfaction with the Agency's services, by sending a questionnaire via e-mail to its users. By completing the questionnaire, users can assess certain aspects of the HALMED's work and give their opinion and recommendations for further improvement. Based on the results of the survey, as well as numerous queries, comments and suggestions that the Agency staff receives daily via HALMED's webpages, e-mail, phone and fax, the efficiency of the Agency, as well as the level of cooperation with users, are assessed and, when necessary, improvements and harmonisation are made accordingly to achieve best practice.
In the survey carried out during June and July 2018, HALMED was highly rated by most of the participants of the survey ("excellent" and "very good").
The percentage of user satisfaction varied depending on the question, where the following aspects obtained the highest marks:
- Competency of the HALMED staff (96,37% of participants gave excellent or very good)
- Politeness, courtesy, and accessibility of the HALMED staff (93,64% of participants gave excellent or very good)
- Professionalism of the HALMED staff in handling complaints (93,63% participants gave excellent or very good)
- Clarity of the HALMED staff's replies to queries (91,66% participants gave excellent or very good)
- Procedure of handling submissions (90,97% gave excellent or very good)
- Promptness in replying to queries (88,89% gave excellent or very good)
- Level of information on HALMED’s services (85,41% gave excellent or very good)
When it came to the quality/price ratio of HALMED’s services, 60,22% of marks were excellent and very good, whereas the promptness of handling applications in 59,09% of responses was rated as excellent and very good.
Based on open questions where we requested proposals from our users for improvement of our services and proposals for additional services, as well as their opinions, recommendations and comments, we received a lot of positive feedback. In a large number of comments, the users praised the overall work of the Agency, with an increase in expertise, openness and professionalism of Agency employees and their assistance during the implementation of the procedure. Furthermore, cooperation of HALMED and Marketing Authorisation Holders has been highlighted as exceptional among the regulatory bodies for the medicines of member states. Proposals for improvement were mainly related to the further acceleration of the implementation of certain activities.
Instructions for implementing additional risk minimisation measures
Following a number of suggestions obtained regarding the need for instructions for implementing additional risk minimisation measures, HALMED has published the said instructions along with the national form for their preparation. Instructions and the form can be found here (in Croatian).
Monitoring the status of pending applications
A number of users expressed their wish to monitor the status of pending applications after the procedure is initiated. We are glad to announce that the creation of two applications that will enable, among other functionalities, the monitoring of application status, is under way. It is an Extranet portal for monitoring applications for marketing authorisations for medicines and Extranet portal for monitoring requests related to medical devices, licenses, attestations and certificates, which will enable monitoring of most of the applications submitted to HALMED.
In accordance with the growing interest in educations we have organized over the past period, we have tried to increase the frequency of their implementation. We have been conducting workshops on medicinal product regulation, as well as on the regulatory framework for medicinal product distribution for some time. In addition, we have organized a number of other educational events.
Continuously following the needs and interests of our users, we will continue with the intensive conduction of educational activities in the forthcoming period as well. More information on our educational events is available in the Seminars and Workshops section of our webpages, or here.
Answers to your questions from the survey
In the survey we received a question from our users about issues regarding HALMED’s actions in ensuring consistency in the assessment process and variations handling. We achieve the consistency of our procedures in the following ways:
The department assessors for quality, safety and efficacy are organised in working groups according to their field of expertise. At working group meetings that are held regularly, assessors discuss together general issues concerning the assessment and assessment of certain applications. In addition, at meetings of assessors working groups, regular presentations of regulatory and scientific guidelines are held, followed by discussions related to interpretation of guidelines and common and harmonised positions and opinions, according to which assessors proceed later on in the assessment. Minutes are taken at working group meetings that are available to all HALMED’s assessors.
In order to ensure additional consistency in opinion, the assessment of documentation submitted alongside the majority of applications (all marketing authorisations, renewals and variations depending on the need) are confirmed by the Committee for medicinal products, HALMED’s body gathering internal and when needed external experts with different expertise. Meetings of the Committee are held every week. Minutes are taken from the meetings and are available to all HALMED staff members.
Procedures that are obliged for assessors are set out in standard operating procedures (SOPs). SOPs stipulate that every assessor is obliged to check all previous opinions in procedures that are linked to the pending application and not only for procedures conducted by HALMED, but also from procedures conducted by other agencies and the European Medicines Agency (EMA). This is achieved by searching internal and common EU databases containing all the essential elements, including electronic assessment reports.
Based on the above, HALMED ensures the existence and maintenance of regulatory and scientific memorising at a very high level, which obtained one of the highest marks (4.5) within the programme of Benchmarking of European Medicines Agencies (BEMA) within the EEA network of medicines agencies.
When comparing assessments of different applications it is important to bear in mind that different applications for the same medicines or same active substances may be substantiated by different documentation that is accessible only to HALMED, which may result in a different assessment.
In addition, it is very important, among others to take account of the time of submission and assessment of every individual application. Namely, the European regulatory-scientific environment in the field of medicines is very dynamic with new guidelines that are being adopted continuously and previously authorised renewed, supplemented or modified. HALMED is obliged to work according to every new guideline coming into effect, to maintain the consistency with the approach to assessment in other EU member states. When doing so, it is not always acceptable or possible to implement new guidelines on previously authorised medicines that are already on the market. Depending on the need, this harmonisation is carried out through regulatory actions like renewals or upgrading or under official authority immediately, if it is about changes in new data modifying the benefit/risk ratio of already authorised medicines.
Also, in order to achieve a maximal harmonisation of the procedure for handling safety variations, we have established a special co-ordination group of assessors for safety variations and renewals. In order to harmonise this procedure at referrals, a creation of a SOP for handling these variations is planned.