foreign foreign [Music] [Music] good morning dear colleagues we are glad to welcome you at our webinar registration of medicines in Libya today we will work for one and a half hours uh please feel free to address all your questions to the speaker in the comments section uh we encourage you to do that um attention important thing is that today we have no video recording of the webinar just live today I also would like to draw your attention to a number of trainings devoted to medicines registration which Farm Education team is working on right now we plan to organize more than 50 respective trainings in the coming year upcoming trainings by countries are the following Vietnam Azerbaijan Lebanon and Gordon if you have in mind any topics that might be interesting for you please share with us your ideas by email we will carefully check and we'll try to work on them in the first priority well that's all from the technical side and right now we are ready to start I am very glad to give a floor to our today's honorable uh speaker uh Marina bakrowska Regulatory Affairs senior manager in international a Pharma company uh Marina we may start the floor is yours hello good morning good afternoon everyone depending on the time zone I hope you can hear me and see me well and the slides of course important so today's session dedicated to the pharmaceutical Market Libya and we will together go through the main requirements and look closer into what is um and how it is done the registration of drug products and marketing activities in this country maybe first we start with the agenda you saw it already so just to serve up we do some introduction and the country overview it is important to understand there are specifics of these countries which will also help to understand the pharmaceutical Market situation we will review some available key information about importation and see then a close-up the regular 2fs requirements about manufacturing site registration the so-called local registration of the manufacturer or a GMP uh then a review of application forms plan of the inspection um some information medical device other regulatory aspects which might be important and of course conclusion and question and answer sessions guys um also a few words about myself [Music] I am senior manager head of the department international Department Global Department responsible for emerging markets or so-called rest of the world I'm working for international pharmaceutical company headquarters are in Switzerland and we are supporting a lot of Mas worldwide I'm working with regions and our regional colleagues or Partners in Middle East North Africa central Africa English-speaking Africa or French speaking speaking Africa Central Latin America countries and some others you can see that we are doing a support of all kind of we go to the activities life cycle so I'm going to share my experience with you today some also important information and disclaimer because uh I can only represent the information which is available at my site it is not at all any advertising or or any legal advice this is just the information and experience I'm sharing with you and also always check the information if it is still valid or there were some implemented updates value in a constantly changing environment and yeah so I'm sharing the information available for my practical experience for today and that is no conflict of interest from myself so now we can start to review the or more closely the Libya country so it is a country which is um located in Africa in North Africa is always belong and very often belong to so-called Mina Vision Middle East and North Africa because it is a Arabic country sometimes and in some countries or companies or the structures it will be also related to so-called Levant region together with countries Iran Iraq Syria uh Egypt even Israel but officially it is a part of such a regional communities as AMU gomeza you will find a explanation of the abbreviation so the most important is to mention Maghrib Union so Maghrib Union these are countries of um French speaking North Africa countries Arabic also so it is a Morocco Algeria Tunisia Liber yeah so as I already mentioned official language it is a Arabic country Muslim so official language will be Arabic and from the old dialects we know some Modern Standard Arabic currency sleepy and dinner and you can see also the latest available official population number so despite of a quite big territory the population is not really big due to different factors and also natural because the most part of the territory is the desert nevertheless officially a climatic Zone it is two and three and by the who it is assigned to clematics onto this may be also important to remember when we speak the pharmaceutical products um let's just some available information about Liebert probably you know there was a big after the so-called Arabic Revolution or the local War uh there was a big damage and since then it's still in staple from a political point of view and also very um country Visa very closed not uh sharing a lot of official information but you can also find some interesting metrics measured by International organizations and both European worldwide and us so there are some index ranking of doing business and still maybe I will mention [Music] here that from North Africa countries Libya holds the largest oil reserves and it is a uh just the basis for actually economic potential and yeah we will review it further um information about medical sector so um in general of course uh since all the economic situation was severely damaged and continues to be severely damaged so um medical sector of course suffered a lot that is quite full stop of any local production so I it's a Health Care System suffering the shortages because of issues and sanctions during many years which influenced of course the importation and supply and every year [Music] 711 it is Libya is reported among the country with the highest humanitarian needs foreign I think since uh past a few years is also observed some changes so we will review them later but also important to mention if you you if you see the map uh the uh you also can understand that the Border countries are also not um are not so much highly regulated and there are a lot of issues to control the borders between those countries so from the south it is Sudan and it is also a big gap which cause the counterfeit circulations in this country as well okay um so you can see the some numbers finally related to Pharmaceutical so it is a official what is registered as a pharmacy drug stores so the channel of distribution for pharmaceutical Market that is um uh like quite a few branches of registered as limited companies so it is mostly a private business and yeah it also has its own specifics so it is also understandable that it's not covering the demand of the population and of the market so that is a attendance which allow us to speak about some potential growths so the regulatory Authority the main regulatory Authority which is regulated uh medical sector is a Ministry of Health it is also the main regulator uh for control of drug circulation and the issuing all the official regulations decreased or circulus as they also call and um covering and governing the medical practice education in medical area so on and so forth mostly as you can see from the slides of the distribution is done uh by [Music] um wholesalers so they are also like registered as a sole company and um we will talk uh it about it uh closer later about the type of the company so the size of a market is very small uh because it is suffering from the shortages official sources report shortages in even very key and essential medicines like medicinal products to treat diabetics cardiovascular tuberculosis Etc so this the general overview and the size of the market in in [Music] currency so the [Music] um United Nations deported in 2022 um 230 like around 200 35 uh so it is growing now the numbers are growing out the market so you can see some Trends up and down but now there is a trend to to grow because it's uh uh more than 30 percent more than the previous year and we all understand that it was still a year of copied um and um like massive closer so there are some Tendencies and of course the key players in the in the country would be public hospitals and private providers of the services who issue all the request and demand and also the medical supply organizations so there are there are centralized as well majority of medicinal market and pharmaceutical marketing Libya is covered by the importation so as I already said that is quite no local production and this is also uh showing the inside the opportunity to to enter the market because of the low competition from the local part still as I said the humanitarian needs are very high and also include the vaccination support to Pediatrics and basic ads Health needs so there are many official reports issued by The Who and United National organizations I encourage you to to investigate more to read so it can be also interesting for the development of strategies or to think about the cooperation with for example International Organization so this is the overview of the country just to make a general impression of what is the situation there and of course we uh moved the market entry prerequisites so uh there are Libyan Ministry of Health Organization and there are requirements for every drug and for entering the Market so the Basics are captured here not ask you to read at all but just to sum up and so the every company the business license is required for not only pharmaceutical but also part of pharmaceutical like food supplements medical devices nutrition products then every uh pharmacy drugstore is also required to be registered by pharmaceutical pharmacists syndicate and pharmacists indicate so a licensed um and cover the educational part and control the pharmaceutical practices then there is a the department to control so the uh Food and Drug control center by the established by the Libyan Ministry of Health this organization is performing the quality control and all required actions related to that so they are also a part of uh review of documentation and to control the Conformity of imported goods then there are some requirements for the custom clearance which is important for the company's importation activities so all the important export activities require the license from the Libyan custom Authority and there are some specifics related of course to Pharmaceuticals and the medical devices and drug product registration is also now required so we will speak about how to obtain this number and how it is controlled by this also there are requirements for the registration of a drug product so there's a five key requirements which have to be met for the entering the entering the market um yeah I'm checking if there are any questions so far no okay so we can move forward and we start with the reviewer in those requirements so business uh registration of the company in Libya so there are official commercial law uh and decree of Ministry of economics uh which uh cover the possible options uh to register a business by the international company so I assume we all are not libyans and this is why we are interested in this information how to uh how to start be present and if there is a option to register our company in Libya so the branch office is the option joint venture company representative office okay the these three are uh very much popular in international business area and also in pharmaceutical and big Pharma unfortunately I need to I need to mention that uh there is a quite a few weeks uh information almost no information how to establish this big Pharma companies uh so maybe the main reason is because there are strict conditions for each and it's just not interesting for Farmer laughs I will explain so for example for the joint venture company uh it is uh officially required that their stocks will be owned minimum for 51 by the Libyan national uh nationality uh so this person who is liberal and plus the executive director for branch office and for joint venture and for representative office also required to be a local person from a Libya and there are also some other moments which for now are not widely used by the pharmaceutical markets so it's not really the uh usual office and representative offices are mostly run by Bank sector for example so the option number four will be the most copula and the most of use by the farmer um big farmer and all others or other players it is operating through a Libyan distributor or the local commercial agent that's the most popular and maybe to the start to only first steps of establishing the relationship with this country will be the most recommended option because it will streamline a lot of activities which already are performed and they own the required documents and also will guide you through the required next steps National competent authorities of course the I provide the overview so there's a Libyan Ministry of Health and their official Pages everything is of course in Arabic language which is not very friendly to read There is English translation uh button but I need to admit that it's a very randomly and not updated or very seldomly updated not uh always there is a fresh information located to the even official websites maybe the situation will change and yeah so I encourage you still to to to try and to see how it works later so there is also information and Documentation Center provided by Ministry of Health and there are official contacts and yeah there is also an option to to apply with some questions um to the Ministry of Health and to set up some comments uh as I already said the Food and Drug control center which performed the analysis and the control so there are also official page from their side also in Arabic language so for the moment and for the start of doing business with the Libya of course you will need um someone who speaks and reader and understand Arabic language those will help a lot in many communication so this is also can be your local agent and the pharmaceutical syndicate so they also have their web page and some news on how they perform GDP examination some of them perform some trainings and also via pharmaceutical Syndicate it is possible to perform lectures and to spread educational information for uh pharmaceutical evidence about the problems now finally uh regulatory FS requirements so what kind of documentation and procedures we are facing when we want to register our drug products so the key array requirements are not as much detailed as other International requirements we are probably used to but still there are some specifics so there is a official law in Libya since 1973 and which demands the registration of medicinal against and medicinal products in Libya and before the the entrance to the Libyan market so the procedure has been established long time ago however it was not really well followed and in a very detailed [Music] a controlled by them also so the there are two main procedures which are required the first and from there we start it will be the registration of every manufacturer and this process takes approximately one to here because it is include a it does include a site inspection and it takes time plus there is a following registration of a finished product an install product this procedure takes about six months yeah and it is because the very important prerequisite for it will be that the manufacturer are approved already the proposed them a holder or the holder of the official holder of the license you can choose any strategies that is no official demand that a Maya holder should be also a local company and somehow you should not worry that you transfer your IP to any local company so you can decide gorgeous then um there is even I mentioned official timelines are not available [Music] period then only just um only just recently [Music] the importation and official authorities started really to check the drug product registration previously was all the importation was really governed by so-called importation permit so it was a document requested and issued only based on the site registration documents and Drug product documentation was not submitted not reviewed of it like uh and like an official demand to enter the market so that was described in the law but unfortunately not performed by The Authority themselves there was issues with capacity and also with them the right process to control it now there is a now that I've observed some changes because the importation permit uh were stopped even those issued before they were stopped until uh the receipt or of submission and approval of the drug product information together with a manufacturing site information and we start with the site registration requirements so some more details you need to prepare and fill the application form uh this will consist of the official not application and plus additional registration forms we will review more in details how they look like in the next slides um then important that or original copies of the application which are going to be submit they also need to be stem and signed so it requires wet ink like we say signature and stamp by the manufacturer officials and also together with a scan copies but also the soft copies legalized application is not needed but it will be also describe later so you collect all this package and dispatch these two for submission so Amanda documents which are required to enclose like an annexes will be of course the value GMP certificate from the country of origin it means the from the country where the manufacturer is located and operate maybe one important note from my personal experience is sometimes the situation occurs that the company is located in one EU and GMP might come from other awesome EU country it happens quite rarely but it can happen then there is a need to attach additional clarification letter and maybe uh will be also important to enclose local GMP um equivalent document so that this will be the solution for such cases um the same if we are speaking about sites which are outside your Zone other countries so it is of course officially required to have a local GMP certificate or equivalent plus it will be really supportive to have a GMP issued by the some countries among you Us and other countries are highly recognized worldwide then it is required to have a CPP for the product which are produced by this manufacturing facility of course number one complementary beneficial will be to have a cpps from FDA or Ma or the whole certification but it is very often not applicable for companies so if we say in this in this case you just Skip and it is not obligated to have this so obligatory document will be free sales certificate or CPP certificate of pharmaceutical product from the country of origin so it is stated for at least five products of course it can happen that you can have less interest so if you or the document from the manufacturing side is uh ownership of other company and it's not so easy to to get them so it's also a point for negotiation with uh with your local agent and with the ministry of house in each and specific case so there's a points which can be discussed also there will be this um list of countries where products um uh registered so it's like worldwide status um I think huh yeah I think I think this is clear what does it mean so I don't need to explain this uh you you take those products which you are interested to to register you start with the manufacturing site with a manufactured but you already provide also the information where else which countries uh receiving these products where it is supplied and a manufacturing license the what is similar to GNP certificate explanation um additionally of course there is a need to be pay a registration fees so for the moment it is about 5000 Dinars but the situation can change so check the latest uh what what is available then also a site Master file letter or the statement suggesting that dates for the inspection which are suitable for for your manufacturer or for you if you are also represented if the manufacturer then um a full list of products planned for registration and supply from this manufacturing site and annual report or financial statement for previous two years uh this is a complicated document and especially the International companies they are really actually all companies are there and financial departments are not willing at all to share such information because it is confidential and is highly sensitive so for this document uh there is the possibility to negotiate this local agent and to prepare let's say to to align and to prepare the submission of this documentation directly to the Ministry of Health department so as a confidential document to avoid the a chain a long chain of transferring the documentation so there are options you can check with The Courier Services there are options to ensure security supplier of documents confidential documents to such authorities samples of labeling so they are stated as a samples of labeling also they will accept as a picture of the products but better also to have like a artworks provided and potentially also the examples the physical samples of a product may be requested to perform some analysis so there are not for all the con the official certificates like CPP manufacturing license GMP uh such a documentation have to be legalized by the Libyan Authority and all documents have to be translated to English which is uh you know clear and officially of course if you operate via the local account or The Local Company but the all information is from other companies that will be a need to have a uh distribution agreement signed with this uh against the local company over and uh and or uh if that is confidential information then there is an option to prepare such letter of authorization and is a letter of authorization will be uh confirming the relationship with the company who will submit your documents and pay the fees and lead the communication on your behalf uh site registration forms there are examples provided and translated um so these form contains the key information required to be provided by manufacturer so this is a first note that it's uh it has to be you see it with a marked with the yellow so it has to be complete by the manufacturer so even if you operate and you have only a contract manufacturing organization you need to uh agree and ask exactly your representative of them a manufactured organization to feel it and to sign it there are some general info uh also mentioning the type of submission will be initial or the changes or the renewal so the terminology differs a bit by the census similar and I hope this is also clear then title Pages authorities so that is quite a list of general information and these [Music] these documents will be also required to be submitted for site renewal in five years so then and if if you have any serious or changes during those period of validity you need of course to discuss it also with your local agent and or with the Ministry of Health with the help of a local agent uh which changes exactly required to be submitted it's a the second page of this application form and as you see there's also required to enclose a lot of additional information from the about the facility itself some plants and [Music] a list of equipments details for Persona also and you you can see what is applicable to your case and discuss with the manufacturing organization uh what kind of what level of details in each and every supporting uh file you can provide so there is a list of documents which you might need to enclose but there is no guidance for the list of details for each and every so it's up to you to decide and to agree uh with you again there is also of course some general like a concern that the information is correct and true signatures and I I'm just remind that signatures and stamps have to be like life wet and by the manufacture uh these are additional forms um uh related to personnel also with the some details related to personal of the manufacturing site including uh total numbers and Company structure and qualifications so this kind of information what is applicable you can include either with the typing so it's not allowed to fill the form with the hand rating so it's important to type and or you cover it with a Nexus virtual apply if it is so you can you can make just a reference to a certain document and a page and order the page also the form number three sorry detailed information required and requested for the production and premises uh so this uh is more about the manufacturing side building and specific operations and uh [Music] relations to a certain area also the information about plant general manager including his CV and title and name so these details so this will be the form number three uh it's also required to provide information about heating ventilation air conditioning and control and of environmental parameters so this information you are again either type inside the form or enclose with the annex and make the referrals the part number four quality control part so it's also self-explanatory it's related to all processes and how it is covered uh the quality control and the quality assurance uh uh starting substances and in process control then finished product control control of packaging materials Laboratories equipment in these Laboratories and uh other details like self-inspections and system of quality assurance and the Change Control procedures so you will see you can see the details what can be requested and examples of documentation you can also provide just again a note that all documentation and annexes which you are going to attach as a supportive representation you need to translate that to English language so and in case of any additional request and during the site inspection of course the documents uh can be requested to to be translated so just for you to be prepared to this then um you collect all this information the legalization of a key official certificates are done you collect all this files I agree with your local agent the payment of the fees and submission is done the process of review and registration committee as it started this can take few weeks uh also again there is no official time during which they are obliged to review so it's uh also very often depending on internal capacity and or the other us external factors but also maybe to to note here that uh the Arabic countries they have other schedule of holidays and this also influence a lot the schedule of working of the governmental authorities and others so just to remind like that it's a Friday day off officially and week starts from Sunday there are also other time periods and national holidays which are long and very specific a way of working during the Ramadan so this kind of things may may influence the timelines even longer if there are any questions they of course will ask you to provide clarifications or some additional documents then there will be a plan and a time to agree and set up the site inspection site inspection on-site inspection personal presence audit is a obligatory absolutely so even during covet there was no exception and were just registrations were put on hold until with this with a commitments to perform such activities then it is important to to explain that of course the uh the site inspections will be um an exercise with a long planning because it will require the uh required of some actions at the manufacturer the preparation the availability of a gift staff absence of any conflict with other critical activities and also a planning an agreement if any uh special production activities have to be covered so some some related to the specific list of products and there is no uh conflict with any other uh regular activities scheduled from for the site so it is usually some back and forth communication to agree the timelines well it is also suitable for inspectors from the Ministry of Health will receive the official inspection invitation from the manufacturer so this will be like um one additional document later required and very important to mention that all probably major of countries uh will require issuing visa for the inspectors to travel and this will also take some time so during this time of setting a Visa and planning the trip uh you will also have this time to agree the scope agenda of inspection and Ministry of house will suggest a number of inspectors and duration or there is again no official uh regulations will be a point or from the scope and the number of products but basically from practical experience and inofficially I can say that it will also depends depend from the country where the manufacturing site is located and we have been requested and suggested the three to five inspectors and duration for five days for one manufacturing site with only oral dosage forms solid dosage forms production so just for you to consider this information what is also inefficiently but important to mention about site inspection that you or you need to understand that there will be also some um in official requirements for covering the business flights and special hotels and maybe even uh uh well of course dinners and accommodation traveling costs to be covered also can be asked some sightseeing or some program uh for inspectors so I I pointed to think and to compare with your company compliance requirements and to discuss this very much in detail with the local agent in advance then usually like all the Visa arrangements and the traveling and inspection uh will be not less than several months so it will be like a final uh final final issue of the Visa even not earlier than they say maximum three months but now we need to understand that it's it takes longer and the Ministry of Health arrive to the plant provide the inspection there there might be some additional questions uh during the inspection but they will come back with you so all the other steps uh very looks very familiar to the other site inspection and local GMP inspection so they will prepare the final audit report and of course in case of positive result there will be already like uh verbally communicated decision and this will be important moment to know and to start some other preparations so then it will be a certificate issued and used by the all-importation permits and activities and for the registration of the drug product there's a registration a certificate for the manufacturing site is is valid for five years then it is required to submit a renewal but again if some critical information is changed for the manufacturer during this years you need us to discuss the a need to submit to resubmit files or to submit some amendments and what it will mean in regards to all other activities required I don't know if you have any questions because um yeah not for now um so we move maybe with some strategies which we have discussed uh also and tried so it is possible to prepare and submit files together with the site manufacturing documentation it will only not uh start uh Authority will not start reviewing them and or it will not for sure issue any approval before the site manufacturing manufacturing site is approved so it's better not to move to too too fast too early and as I mentioned on the previous side slide so when you when you are receiving already the positive conclusion for the site registration it is it makes sense it is possible and makes sense to submit uh files for drag product or maybe a bit earlier just before the visit if you are very much confident and in agreement with the local agent so these are possible options to make the submission earlier and expect some earlier approvements and also important to mention that the in case there is several manufacturing sites involved so for example you have a bulk manufacturing and then Packaging done by some other manufacturing facility so you explain this to to site audit also you explain this and discuss this with a local agent and it is recommended to start with the main manufacturing facility where more than 70 is done I mean bulk manufacturing site and you start with the manufacturer where you have a the most products coming from and later and with all successfully performed activities for this Main site you can also try to negotiate regarding the other facilities and how to register the packaging sites alternatively there is an if the manufacturing sites are located not far from each other or maybe the same city or a region it is also possible to plan it for the one visit but also negotiate this with the local agent that it is included and approved to be included in the agenda sometimes it it will be requested to have like a break time between two different facilities like day or two is again not described officially but it's possible then we are ready to submit Finnish product registration that is also the list of requirements so the package will look like this there's a registration application form again cpps if possible centralized but it's just included into official requirements so I don't delete them but very often it's just not applicable um legalized CPP for sales certificate then a document which previously did not appeared so it's a price certificate and it's also need to be legalized so this is a suggested price and Justified price for public and private entities and you will you will need your commercial team also to work with the local agent on on the instructions on how to prepare it and the registration uh certificate fees payments is also for the moment is uh officially this amount and worldwide registration Stratus drug Master file artworks and Finnish product samples so um as you see it's a quite simple list of registration drug Master file of course so for the detailed document you [Music] um you need to see uh for the samples and artworks and you will need to agree uh which packaging will be accepted so it is possible that you don't um that you don't prepare only Arabic language but it's better to have Arabic and English or at least English and this will be required to to be agreed between local agent but this I this this kind of discussions you will do during even the site registration so it will be much more required to discuss in advance so this documents prepared stamped legalized and Central Authority uh but we will recommend to also prepare like an abstract [Music] additionally so there is no ctd format at all established at Libya uh but it is recommended or it can help let's say to speed up review and simplify you uh if you can extract a certain information from a module 3. and provided uh enclosed to this application form um what kind of additional statements may be required as a Muslim country and uh it will be definitely uh required to ensure that the product does not contain alcohol or a pork so uh sometimes they they will ask to issue such statement or you can discuss if this is needed in advance it is not included into official regulations but maybe helpful so just the general statements if you have alcohol used in your production but then there will and it is visible from the formula make sure that you have a detailed explanation that it is eliminated during the production cycle and the finished product is not containing alcohol at all because this fully banned then it can be requested a letter of a boycott of Israel um if it is if your company is a partner or the part of countries where such letters are not officially allowed so also they're just discuss what kind of statement and explanation of relationship and supply chain will be sufficient to cover this topic reference samples and standards again only if that is a plan to perform in local Libya authorities control quality control of the goods pharmacovigilance topic so we are we have we have we have finished with the registration I don't know uh if there is any questions to know okay good so pharmacovigilance officially is described as the resolution from 2015 there is a system for auditing and surveillance however it is uh even not started until 2017 and for now that is quite a few notes so this uh the authorized body for this uh pharmacovigilance is Libyan from a covigilance department but um they are still lacking the processes and internal capacity to cover this so there were several investigations conducted uh by different Representatives and learned that quite a few quite low percentage of Pharmacists and doctors are aware about such system and their how to participate in pharmacovigilance activity so reporting is not officially is officially working but not practically uh working well and fully functionable and World Health Organization uh perform seminars workshops educational materials together with some other organizations how to establish really well working adverse track reactions reporting so there is now since 2019 Libya is a member of uppsala monitorial Center but again and all official [Music] sources I have been able to reach uh is not stating data in a structured way and any statistics from Libya assaults mainly done by the companies who have marketing activities in Libya and they report any cases but very few and most of the cases also what interesting from the investigation uh happened from the from the lack of knowledge about drug product to prescription and really not following the good pharmaceutical practices itself that is also for serving this issue uh European Union has funded who World Health Organization they have organized special trainings and actually established the informational system where and it was officially released by the government of Libya and introduced that medical doctors and pharmacists can find that information can can reach and find the correct and up-to-date information about drug lists that retropolitic classification so indications of pathologies and all the aspects it is a really uh big step and important achievement for Liberal medical sector because previously it was really not in place and several investigations showed uh really lack of information available and accessible by the medical health professionals in Libya and maybe some few words about medical devices some general requirements so this is a one slider here so that is also a requirement to register all medical devices which enter Libyan Market the documentation and languages is both Arabic and English and the classifications classification systems can be all accepted because there is no such locally established or any harmonization with the official International requirements no also information so far the time of approval and validity of license if you can also Imagine I can be uh some additional information requested but it all will depend on the really necessity and essential need for this or that device presence of other competitors so the usually registration is uh accompanied with the like a purchasing program or standard tender program so the tender announcement usually contained also requirements for the documentation and the process of review of course it can be also done for the private sector and private orders done by your local representative office so there are examples of documentation mentioned uh also the covering technical documentation which is quite a usual list of requirements then for still first trial medical devices there will be also additional requirements which which you have to provide and the documentation as well then certificate of analysis the samples of finished product if it is applicable for a three complete tests or the sometimes it's really uh if only you don't provide something really super expensive then you need to negotiate this but this is usually required the amount of product for such analysis and if you are dealing with in vitro and also the stability studies requested packaging and labeling so a lot a lot I can mention this uh repetitive the general requirements so the the packaging materials shall ensure the safety and quality of the product the adequate with the humidity and heat here we remind ourselves that the official requirements uh the whole classification make Libya climatic Zone 2 but still um uh ensure that the labeling contain all required warnings If the product is sensitive then all the other information or you usually with your standards let's say the minimal information will of course require the trade name the manufacturer responsible there are all the um all the information about contained so this uh more for medical devices but for the drug product you follow your guidelines you have in alternatively you can take the guidelines from HCC for the labeling then if it is a tender Supply there are also some additional uh requirements for the packaging and their documentation so if it is official governmental tender there will be some [Music] additional requirements which will prevent of uh in compliant [Music] and then activities later there is also a product as a Veterinary I know we are now discussing more medicinal but just a few words so uh in case your company or partners are also working with this kind of uh production and products so there are also some health regulations covering this uh kind of drugs and it is mostly required for and used for food production animals so there is a quite a few cases where it is for cultural animals and because it's just uh traditionally not really [Music] common and that is also the national Veterinary drug list which shows the drugs available in Libya for this purposes so there you can also discuss if you are interested in this kind of business or you have it in your portfolio this can be an option so uh foreign ERS how they look like so there is uh absolutely I am not advertising anything but just examples what I was able to find in uh internet uh there is uh quite a number of uh pages and companies or company Pages or the general Pages where you can find information also related to medical supplies equipment and Drug products and there will be um attendance issued by non-governmental organization also government organization but mostly private sector you can also scroll or scroll and you know see what are the options then also the during the standard will be done a lot of negotiations and reviews so I was always a special options also available but they are depending on the essential um let's say the the night the nature of the product and this need by the company so this is just examples how to search so I'm not risk I'm not recommending any but just another point that tips searchable processes also to mention processes which are not established not regulated officially so far or there is no clear understanding how this processes are working so the year there is no difference for the application for Innovative product genetic Abridged Etc so still there is no uh clinical information requested in the scope of documents as we have reviewed so you've seen that uh so it is not required there is also not clearly mentioned the life cycle management so there's uh there is a required renewals variations but no guidelines specifying how exactly uh and which documentation is allowed to to cover and yeah and this kind of exchange you need to discuss all the time uh with the local agent as we also review it and discuss the ich guidelines and ctd.c form what is also not included into officially into our guidelines but it the ich guidelines will be potentially like Case by case and to specific uh requirements of course a part of the review like for example stability um publicly disclosed information yeah it means that that is uh very as I showed you the web pages on the beginning so it's really not very well updated and it's a very hard to retrieve the latest current up-to-date information about the registered list of registered medicinal products and manufacturers and it is not publicly disclosed there is no list of all actual and up-to-date uh registered product information because there is no process for labeling updates as well and that is not very clear the process of selections of medicine to be a part of National essential medicines at least in this process to to change it to review control of purchasing the same so this prescription category and antibiotics and other medicines are really dispensed very often without any controlling done well or and there is quite a lot of consequence issues related to that and to the health of our population so this the same for advertisement and that is not well control of the promotional practice Etc so these are Main and actually uh these are a space for improvement and installation and good practices uh we are almost the end of my presentation and these are these are conclusion so um how we review together the requirements and the specific of the market the market was severely severely damaged and steel remains in this condition uh and uh instability in the governmental area and of course the Medical Center medical sector includingly but there is observed some Trend and some improvements into the processes with the help of international organizations and [Music] um and also some improvements in the infrastructure in the development of pharmaceutical distribution channels and of course they have stronger demand in the highest standards or in the amount of treatments and the covet situations also showed the need to improve the internal uh coverage of this treatment standards because all traveling was also blocked and closed and ad hoc requirements were not met and um the same is a a reason a requirement for a governmental changes and Improvement in in the following of local standards the control of goods which are on the market and control of a pharmaceutical activities so the despite of all this let's say in spite of all these complexities which probably can sound confusing that is uh still a big potential because of the natural resources concentrated there and growing needs of the population so if if there is an interest and a possibility to spend this time for registration and make some flexibility and with a some processes which are not really well and described but still uh if you find the right partner and you understand the specific of the market and you have the essential goods and interest to support with the required medicine and medicinal help this will be really a window or window of opportunities because there is a trend and a potential for development of this Market okay I have the question which of language is used for artworks so the the most of the majority of drug products are in English package because it's or the English plus Arabic package so it is uh not I'm not sure if this requirement which is allowed any other language but potentially a package is from International markets are allowed if they are accompanied with the English it was a latest information but there is no regulation for that so it's like a very good to have both but at least English um Marina thank you very much for very retail content presentation we are very grateful uh thank you very much for your time experience and attention uh during the seminar uh we have so far only one question um your colleagues if you have any more questions to Marina regarding the topic please address to one of the emails of farm education uh we will forward it to seeker and we will make sure that you receive the answer well that's it for today um thank you everyone for participation and have a nice day thank you for attention and take care of have a nice day have a nice day see you at our next webinars goodbye