We are now proud to now offer for hire our 10m x 8m ProLyte Arc Roof Stage (in the past a product of this size and standard was only available to hire from the UK).
With our vast knowledge we have been asked to specify and install light and sound solutions across the island.
There aren't many 19-year-olds with the ambition to start their own business, but Dubuquer Josh Beytien is one of them. Beytien, a graduate of Dubuque Senior High School, has a variety of skills, but his parents, Craig and Alyson Beytien, knew he probably wasn't well-suited for a 9-to-5 working environment. Josh's parents realized that his work skills carried some significance in an increasingly electronic era, and when Web research revealed there was a local niche for electronic document storage and retrieval, the idea for a business was born.
When an official business plan had been drafted, a professional at Iowa Vocational Rehabilitation Services served as a business consultant, reviewing the proposal to make sure it was viable. Josh came up with the business title - explaining that the mammoth taps into his interest with prehistoric time - and the fitting motto "Where the Past is Present." Soon it was time to start wooing clients. The equipment for Mammoth Scanning Company is set up on a desk in Josh's room, under a shelf lined with books and some prehistoric animal figurines keeping a watchful eye. For Josh and his parents, the hope is that the business will be successful enough that he will not need state or federal assistance in the future. Craig said Josh's family is pleased he has found work that he enjoys and gives him a heightened sense of purpose. As an individual with cerebral palsy, many activities are more exhausting to me than to the average person. The most memorable experience that I encountered as part of my AmeriCorps experience was the service trip in which I participated.
I consider my 300 hours of service, the requirement of the ICAP program, to be not the impetus, but the rock upon which my love for service was built. Ted, an AmeriCorps member now in his second term, serves at the Institute for Human Development at Northern Arizona University promoting public awareness activities.
Daniel and Sarah are high school students participating in a Learn and Serve project that combined curriculum and service. Shannon was a VISTA member who served in the College of Public and Community Service community technology lab at the University of Massachusetts in Boston. Andre is a part-time AmeriCorps member in the Michigan AmeriCorps Partnership at “Southeastern Village”, who has neurological disabilities. Dawn, who has a hearing disability, strove to create a work environment that was welcoming and understanding to those individuals with disabilities by advocating for community involvement and supporting organizations that supported and helped individuals with disabilities. Jared was a high school student with disabilities who participated fully in a water quality testing initiative though a school-based service-learning project in Western Massachusetts. Early in Gerald’s service, he and I talked about how the program could best provide a reasonable accommodation to assist him so that he could perform all of his essential duties.
The representatives of state authorities (in particular Maksym Nefyodov, Deputy Minister of Economic Development and Trade, and Olexander Starodubtsev, Head of the Department of the Ministry of Economic Development and Trade), real business representatives – pharmaceutical companies, distributors and pharmacy chains, international organizations and professional associations brought together in order to complexly and comprehensively discuss the given issues. Dmytro Aleshko, being a leading expert in the area of state (public) procurements, participated in the profile discussion panel, which opened the conference. The abovementioned Resolution proposes to simplify the state registration procedure for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU. Novelties in materials expertise for the abovementioned category of medicines and requirements to such materials deserve a special attention.
It is worth to mention that despite the fact that the Resolution has not come into effect yet, the text of this legal regulation published on the CMU web-site should be considered as final.
Upon the consideration of the provided materials the Antimonopoly Committee has come to the conclusion that given marketing agreement does not contain any signs of the abuse of monopoly and anticompetitive concerted actions conducted by GlaxoSmithKline Ukraine. Moreover, the project team put major efforts into the materials preparation aimed at the justification of Competition Law non-infringement by the drafted marketing agreement concluded with the pharmacies and pharmacy chains.
The document proposes to extend the list of medicinal products liable for simplified state registration, in particular to simplify the procedure for those medicinal products that have already been registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union. The Parliament Health Care Committee did not support this Draft Law and submitted it for further improvement. The Regulation proposes to establish the selection procedures (development of the first draft Essential Medicines List by the Expert Committee) and yearly revision of the National Essential Medicines List. Further, upon the approval of the first Draft National Essential Medicines List the Expert Committee shall revise the existing taking into account the abovementioned factors and sources. The Draft Regulation also established the schedule of revision of the National Essential Medicines List. Please note that the Order of the Ministry of Health of Ukraine as of February 11, 2016, a„– 84 approved the Regulation on the National Essential Medicines List and the Regulation on the Expert Committee on the selection and usage of essential medicinal products. For 28 years, The Legal 500 has been analyzing the capabilities of law firms across the world, with a comprehensive research programme revised and updated every year to bring the most up-to-date vision of the global legal market.
The Concept suggests the implementation of activities aimed at solving the issues of timely patients support with qualitative, safe and efficient medicinal products, immunobiological products and medical evices, and activities aimed at the prevention of corruption and limited competition that lead to medicinal products and medical devices procurement at an over-inflated price. The document authors note that the Concept designates the directions, mechanisms and terms for public procurements system transformation in healthcare sector of Ukraine through the development of modern convenient system aimed at the establishment of competitive environment and further development of fair competition in this sector. The Concept shall be implemented with the assistance of international organizations and donors in three stages during 2016—2018. Stage 1 (2016) – establishment of institutional and legal basis for the reformation of public procurements in healthcare sector. CPO shall fulfill the procurements at local and foreign levels, and if required shall maintain the procurement from international suppliers — import of medicinal products, immunobiological products and medical devices, involve other organizations into customs clearance, storage and distribution, conduct other business activities based on long-term plan principles.
The procedure for insulin products reimbursement foresees that the pharmacy warehouse should file monthly report on the medicinal products sold.
Moreover, the document amends the CMU Resolution as of March 5, 2014, a„– 73 "On the Implementation of Pilot Project on State Regulation of Insulin Products Prices" regarding the definition of the unified mechanism of the state regulation of insulin products prices. These medical devices are allowed for market distribution before their expiry date and not later than 5 years from the date of their sales start without the compliance assessment and national quality standard mark. Based on the abovementioned, the compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date.
Another significant change introduces the opportunities to conduct the compliance assessment procedures during the period of validity of medical devices registration certificate. Moreover, certain changes have been introduced into the registration of the officials responsible for putting medical devices into operation.
In case such entity is not a resident of Ukraine, the authorized representative should be assigned with the responsibility to introduce such medical devices into Ukrainian market.
State Administration of Ukraine on Medicinal Products should maintain a Register of entities responsible for the introduction of medical devices into the market.
The legal support of the development and adoption of the abovementioned Order of Cabinet of Ministers, as well as the above-mentioned order of the Ministry of Health of Ukraine was provided by the Legal Alliance Company in cooperation with the SIAPS project. The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards  in terms of health and level of funding for health care.
The Expert Committee will consist of 12-18 people, it will be composed of specialists with higher medical, pharmaceutical and economic education.
Once an expert committee under the Ministry of Health of Ukraine is established, work concerning the selection of drugs to be included in the National List will be conducted by them. Interested individuals and legal entities can apply with a package of necessary documents  for inclusion of drugs in the National List of Medicines.
Notice of tax assessment is developed for each separate tax due together with the penalties, as well as for each penalty and poena for the violation of other legislation being under supervision of regulatory authorities.
Notice of tax assessment is considered to be submitted to the taxpayer – legal entity if such assessment notice is delivered by hand to the official employee of such taxpayer against acknowledgement or forwarded in a letter with notification of the delivery.
Notice of tax assessment is considered to be submitted to the taxpayer – individual if such assessment notice is delivered by hand to such individual or his authorized representative or forwarded in a letter with notification of the delivery to the address of residence or of the latest known location of such individual.
The new Law provides for the implementation of public procurement with the use of two competitive regulatory procedures: open tendering and competitive dialogue, as well as a non-competitive procedure - negotiating the purchase procedure.
An important innovation of the Law is the introduction of electronic procurement (e-auction), the electronic review system, as well as the implementation of the exchange of information, documents, to provide clarifications in the e-procurement system. Moreover, for the conduct of unauthorized concentration, which did not lead to monopolization and significant impediment of competition on Ukrainian market , the AMCU recommends to calculate the basic penalty in accordance with the total revenue (income) received from the sales of products (goods, services) at all commodity markets of Ukraine. The AMCU made the greatest specification regarding the calculation of the basic penalties in the cases of the infringements of informational character. Moreover, the AMCU believes that if the incorrect information has been provided several times during the consideration of the case regarding the violation of informational character, the total penalty charges shall amount to the penalty for one relevant violation.
It is worth to mention that the AMCU established the reduced penalty, which may be imposed on the respondent during the investigation of the case of informational character and on the applicant in the case regarding the concentration and the concurrent actions if they provided incomplete case information. Correction of previously determined penalty taking into consideration the aggravating and mitigating circumstances.
Declarations with violation of the deadlines for submission for the reporting period in case the application is submitted within its contents. The registers are published at the official State Fiscal Service’s web-site on a daily basis. In case the Main Directorates of the State Fiscal Service in regions, or in the city of Kyiv send to the appellant the decision on final or partial denial of the appeal, the appellant has a right to file the subsequent appeal within 10 calendar days upon the receipt of such decision. The document in its new edition, updated and improved in line with the requirements of the Law of Ukraine "On Prevention of Corruption", was recently approved by the  Management Board of AIPM Ukraine. The project was conducted by Oleksii Bezhevets, partner with Legal Alliance Company and senior associate Lidiya Sangarovskaya-Gurlach.
The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree a„– 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure).
Thus, the new procedure determines that the applicant may have more than one system of pharmacovigilance, for example, specific systems for different types of medicines (vaccines, OTC drugs, etc.). With regards to the authorized person, the new order establishes that in the case of the applicant, who is located in Ukraine, the authorized person must be part of the applicant's personnel. The new procedure defines the document with a detailed description of the pharmacovigilance system as a Pharmacovigilance System Master File (PSMF).
An important achievement of the new procedure is to establish the requirements for the system of risk management in pharmacovigilance. In contrast to the existing rules, the new procedure provides for the obligation of creating a risk management plan. In concern with medicinal products that do not require the creation of risk management plans, the applicant must support the specification file of important identified risks and important potential risks with the aim of preparing regular reports.
In terms of other amendments foreseen by the new procedure, emphasis should be given to the advanced categorical apparatus and a new player in the field of pharmacovigilance - rapid response groups of relevant departments of Health, which are responsible for investigating all serious adverse events after immunization and some others. Therefore, the adoption of the new order will contribute to the harmonization of national legislation with the European legislation.in the field of pharmacovigilance. It is to be recalled that  in their time some of the provisions were "the bone of contention" between the regulator and the subjects of the pharmaceutical market.
Therefore a situation may arise where the abovementioned provisions will be in force before the relevant decision of the Cabinet of Ministers' of Ukraine albeit with the edition of order a„– 143. The abovementioned draft legislation proposes the disclosure of information contained in the materials of the pre clinical studies and the clinical trials that are attached to the application for the registration of the medicinal product.
In the opinion of the legislation draft's initiators, the closed nature of such data results in the circulation of drugs, whose effectiveness and safety have not been proved.
The Project aims to supporting of Ukrainian government in issue of improvement of effectiveness and transparence in public purchasing system for medicinal products, in particular, by complying of National list of main medicinal products and medical devices with international standards. This year the event attended 130 representatives of the pharmaceutical sector, specialized media, non-governmental organizations, professional associations, and state regulatory authorities. In the beginning of the session Dmytro Aleshko presented a report on the regulation of the medicinal products and medical devices market.
Taking into consideration the composition of the event members many of whom represented the medical devices market, the regulation of the medical devices circulation in 2016 was discussed during a separate interactive session involving Pavel Harchyk, President of the Association of market operators of medical devices, Natalia Serhienko, Health Care Committee Executive Director, European Business Association, and Darya Bondarenko, CEO of Association of market operators of medical devices. The next session of the conference touched the most current issues of the organization of corporative ethics and anticorruption compliance system in the pharmaceutical business.
Following the traditions of the summery conferences the session on taxation of pharmbusiness was held. The highly topical conference programme did not let the participants to relax and loose focus, just as the regulatory and law-enforcement authorities does not let the sector representatives to relax in the course of the year. Hygiene requirements  exclusively concern dietary suppements and do not apply to medicinal products, functional foods and special dietary foods. Hygienic requirements set requirements for the content of dietary supplements, in particular, the latter indicate that for the production of dietary supplements  vitamins and minerals listed in Annex 1 of the hygiene requirements may be used, in the form specified in Annex 2 to the hygienic requirements. Therefore  amendments are provided to the Law of Ukraine "On Insurance" , namely by defining sponsor liability insurance a mandatory type of insurance .


The document designates the mechanism for taxpayers’ appeals against tax assessment notices or any other decisions made by the regulatory authorities in the course of administrative procedure.
This Procedure shall not be applied to the appeals against the regulatory authorities’ decisions, actions or inactions of their officers or other employees if the special law establishes other procedures for appeals. Complaints about the decisions of state tax inspection offices are filed to regulatory authorities in Kyiv and regions, to inter-regional territorial agencies. Complaints about the decisions of regulatory authorities of Kyiv and regions, of inter-regional territorial agencies, and of customs offices are submitted to the State Fiscal Service of Ukraine.
The decisions of State Fiscal Service of Ukraine made upon the consideration of taxpayers’ complaints are final and without any further administrative appeal, however may be appealed to court. The complaint should be submitted in writing to the higher regulatory authority within 10 calendar days following the taxpayer’s receipt of the respective decision made by the regulatory authority. The complaints for the regulatory authorities’ decisions and actions should be cited and submitted separately. The taxpayers may attach to their complaints all calculations and evidence, which they deem appropriate.
Certified copies of quality certificates (certificates of analysis, test reports, etc.) issued by the manufacturer for the series of medicinal products to be imported. The Ministry of Health shall within five working days from documents delivery shall issue for the importer a certificate of import confirmation or send a written refusal notice indicating the reasons for refusal.
The Ministry of Health shall issue within five working days from documents delivery the certificate of confirmation for the medicines payment under the agreements or send a written refusal notice indicating the reasons for refusal.
The supplier shall submit the confirmation certificate to the revenues and duties authority, where it is registered as a tax payer, not later than 10 working days after the deadline for submission of VAT declaration for the relevant reporting (tax) period. The intended use of the medicinal products and medical devices exempt from VAT shall be fulfilled in accordance with corresponding legislation. Nevertheless, the tax payers are still obliged to pay advanced corporate profit tax payments for the first three quarters of 2016. The failure to make this payment shall result in imposing on such tax payer the penalty in the amount provided in Article 123 of the Tax Code of Ukraine.
If you have any questions, contact the NC Department of Revenue Taxpayer Assistance Division Toll-Free: (877) 252-3052.
What makes this recycling program different from past recycling programs is that the cleaner is not required to restrict which poly type products can be deposited or required to go through the returns to take out small pieces of paper or other items that a typical consumer may deposit in the bins. I come from a 20 year background of Sales and Financial Services and I dona€™t even remember how many countless conventions I have attended over the years.
Our heartfelt sympathy goes to Cindy Cheatham, Shallotte Cleaners, in the loss of her stepbrother, to W. Congratulations to Millie Thomas, daughter of Marvin and Robin Thomas, Swannanoa Cleaners, Asheville, and to Elizabeth Cheatham, daughter of Allan and Cindy Cheatham, Shallotte Cleaners, Shallotte, on their graduation from high school.
Matt Sigmon of Matt Sigmon Productions gave a good talk on a€?Why You Shoud Have a Presence on the Web.a€? If you dona€™t have a website, he can get you started.
Lastly, Bill Bohannon, owner of Hollin Hall Dry Cleaners in Alexandria, VA, gave a very interesting talk on cost analysis.
Dancing and bidding continued furiously until the Silent Auction closed at 10 pm and the compilation process began so that the winners could pay for and claim their prizes Sunday morning. It was truly difficult for a lot of us to give up the beach to shower and dress for the Sunday evening festivities. Following a brief intermission, we benefited from a recently discovered talent of NCALCa€™s newest member (yep, he joined Sunday night), Alan Hargis, who is a licensed auctioneer. Chris Edwards, NCALC VP Governmental Affairs, reported that the DSCA Stakeholders Meeting was held June 2, 2011. Ita€™s hard to attend a show in the middle of the week, but fortunately I was able to because of my wonderful co-workers. Kreussler K4 Solvent a€“There was a lot of excitement around the Kreussler booth because of the new K4 Solvent. Electrolux a€?Lagoona€? Wet Cleaning system has an exclusive endorsement from Woolmark if you use their complete cleaning and finishing equipment.
Spector Textile has designed some new route bags, marketing material to capture new customers, and promotions for new route customers.
CompassMax Maineline, a pos software company, demonstrated new updates to their software with assembly integration enhancements, mobile coupons, smart phone applications for employees or customers, and cloud computing hosting services. GreenEarth Cleaning has been around, but what was interesting to me was the professional marketing program that comes with being a GreenEarth affiliate. A.L Wilson has developed step-by-step videos on their website on how to correctly use their individual products. We started the show on one side of the convention center and decided to walk one aisle at a time, hoping to complete all the aisles in one day.
Monday morning opened with industry icon, Sid Tuchman, receiving DLIa€™s Diamond Achievement Award.
The show floor contained about the same number of exhibitors, but many appeared to have reduced their booth space. A couple of hours later the front spawned another tornado over Wilson that lifted the roof off Exclusive Cleanersa€™ 8000-square-foot American Drycleanera„? magazinea€™s Grand Prize award-winning plant and collapsed one side wall onto Exclusivea€™s delivery vans.
Fortunately, no one was injured in any of these severe weather issues, and all of the victims appear to have dodged the bullet in terms of loss or damage to customersa€™ goods, which can lead to loss of customer confidence. It was truly difficult for a lot of us to give up the beach to shower and dress for the Sunday evening festivities.A  However, the lure of the Presidenta€™s Reception and a magic show by Captain Jim the truly peg-legged pirate in the courtyard brought us all together for an entertaining hour prior to dinner. Metalprogetti had an all-in-one automatic sorting conveyor, bagging machine and racking.A  Basically, once you loaded the garments onto the sorting conveyor, the conveyor sorted the garments for each order. Unipress and Sankosha both had new redesigned pressing equipment.A  Some equipment taking less space and others offering a new way to keep the heat away from the operator were being demonstrated.
The consolidation of the ADCO and Laidlaw chemical lines was obvious.A  It seems that the ADCO line will be a premier line, while Laidlaw was presented as a service type line.
The next Clean Show date is June 21-23 2013 in New Orleans.A  Make plans to be there to be among the first to view the latest advances in drycleaning technology.
He recently launched Mammoth Scanning Company, a business that creates categorized electronic files of documents and photographs, along with storage and retrieval services.
Then in his senior year, Josh landed an AmeriCorps position at the Dubuque Center for History at Loras College and discovered a new area of interest and proficiency: scanning and cataloguing images and documents.
With funding in hand, Josh was able to purchase the hardware needed, most important of which was a high-quality scanner, and the software for creating an online environment for clients. Josh prepared a PowerPoint presentation for his first business pitch and his parents came along as guests to watch the presentation, which secured him a contract with Hills & Dales.
He is working on scanning and cataloguing playbills dating back to the 1890s for the arts center. The documents and notes for Josh's current project are neatly arranged near the two-sided scanner, and it is at this station Josh can quickly transfer a document or photo from paper to screen. Growing up, I was told that physical therapy and exercise was the number one way to work on building my endurance, mainly so I would be able to be active and productive as I got older. First and foremost it forced me to step it up in terms of seeking out service opportunities.
Prior to the ICAP program, I had only cursory experiences with Habitat through Wartburg’s new student orientation service days, but when I considered service possibilities for my 300 hours alongside the rewarding experience I had with Habitat, it became a natural fit. Although going on a spring break service trip was on my bucket list during my time at Wartburg, I felt much better prepared and ready for full service immersion after nearly six months of training. I had the desire, but I did not have the knowledge or the will to serve when I began the program.
Students produced books that were then sent to Kenyan children receiving aid from the American Red Cross Association.
She helped users, including students with and without disabilities from low-income communities, to learn computer skills, other multimedia applications and assistive technologies. In addition, she taught others about the importance of inclusion and facilitates disability awareness and diversity training to AmeriCorps*NCCC members. She said that "If AmeriCorps, had not opened the doors of opportunity to me, I most likely would still be ashamed and embarrassed of who I am and [how] society has labeled me.
During these years Joe, who has a traumatic brain injury, tutored children, built houses, designed and built wheelchair ramps, surveyed and mapped a historical graveyard, blazed trails, worked at a camp for children and adults with disabilities, and much more. During the project, Jared spoke of all that he learned about water quality and the effects on the environment. NSIP partners with the Association on University Centers on Disability, National Council on Independent Living, Association on Higher Education and Disability and National Down Syndrome Congress to build connections between disability organizations and all CNCS grantees, including national directs, to increase the participation of people with disabilities in national service. Thus, the term for materials expertise conducted by the State Expert Center has been reduced to 20 business days.
The Resolution proposes the Ministry of Health to establish the expertise procedures for the abovementioned products, but with an approval of the Ministry of Economic Development. This Draft Law also proposes to establish the simplified registration procedures for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU. In particular, the team made a comprehensive research on medicinal product markets, which may be affected by the concluded marketing agreement, conducted social and marketing studies, analyzed the experience of GlaxoSmithKline group of companies regarding the relevant agreements in other countries, developed internal standard operating procedures for the Client with regard to pharmacies and pharmacy chains cooperation.
We would also like to express our gratitude to the project team members representing GlaxoSmithKline Ukraine for the fruitful collaboration. The Draft Law was initiated by the Cabinet of Ministers of Ukraine and presented the same say at the Government session.
This Regulation belongs to the package of documents drafted in order to implement the new model of Essential Medicines List.
The difference lies in the fact that all individuals intending to include a particular medicinal product into the List shall have an opportunity to submit a corresponding application including the documents confirming the comparative efficiency, safety and cost-effectiveness of the product.
The Regulation Annexes formalize the application execution Instruction for amending the National Essential Medicines List.
The adoption of the Draft Resolution shall promote the establishment of professional centralized procurement organizations (hereinafter - CPO) in Ukraine, which requires some time and incremental actions.
CPOs shall be established under the Health Ministry decision and shall operate under its supervision. During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration. Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market. The structure and contents of national lists will be based on the latest edition of the Basic List of Essential Medicines recommended by WHO. An important step forward is the need to study whether or not such persons present a conflict of interest, as well as the possibility of participation of foreign specialists with the necessary knowledge and experience in the selection process in the national list,"- said Dmytro Aleshko, who heads the team of experts developing a normative - regulatory package  on this matter.
Such persons shall not present a real conflict of interest, in particular,  they should not be in an employment or any other contractual relationships with producers and holders of certificates of registration of drugs or associated persons. At the same time, the Law provides a number of cases to which the provisions of the latter do not apply.
In addition, the AMCU has specified the meaning of such aggravating circumstances as the obstruction of case investigation.
This method is recommended in case the respondent did not provide any information on the total revenue at the market where the concentration took place and at adjacent markets. Thus, previously the basic penalty equaled up to 5% of the revenue from the sales of the products (goods, works, services) of economic entity in the last reporting year prior to the year the penalty was charged, and if there was no revenue or the respondent did not provide any information on the total revenue – the penalty equaled to 10 000 of non-taxable incomes of the residents.
The written appeal should contain all data outlined in the Procedure, it should be signed by the appellant-physical entity or by the authorized person, for other appellants – the appeal should be signed by the director or a legally authorized representative and sealed (if available). Thus, the new procedure provides a number of new features, the most interesting of which relate to the applicant.
At the same time, each applicant's pharmacovigilance system can have only one authorized person responsible for the pharmacovigilance (hereinafter – authorized person).
Should the applicant not be located in Ukraine, then a contact person for pharmacovigilance in Ukraine, who is a subordinate of the applicant's authorized person, must be assigned on the territory of Ukraine. In comparison with the current procedure, the new procedure establishes simultaneously a clear framework for such PSMFs with the requirements for information that must be contained in it. It should be noted that the current procedure contains a provision, according to which the applicant creates a pharmacovigilance risk management plan, i.e. The draft resolution prepared by the Ministry of Health of Ukraine , does not contain any significant differences , except for some editorial amendments.
The matter concerns a three-way contract, the requirement for the conclusion of which seems by importers to not be feasible. Therefore the draft legislation at hand is aimed at initiating access to such information, which will enable all interested citizens, their associations and professionals to decide on the selection  for the appointment and the medical use of the medicinal products on the basis of objective data concerning the level of proof on their safety and effectiveness.


Being an annual event for the pharmaceutical sector representatives, the Conference focuses on the regulatory aspects of the pharmbusiness and other legal tendencies of the pharmaceutical market. Krzysztof Siedlecki, European Business Association President, Astellas Pharma Europe BV Country Manager Ukraine, Dr. The discussion was held around the current status, potential problems and roadmaps in this sphere.
The session was opened by Legal Alliance Partner Oleksii Bezhevets, who informed the participants on the main changes in anticorruption requirements. Legal Alliance Associate Partner Andrii Gorbatenko, who leads the antimonopoly and competition law practice, acted as a moderator of this session.
Nevertheless, all the attendees remained satisfied with a quantity and quality of the information received at the event and expressed a desire to meet in such a format at least twice a year.
Quality criteria for nutrients used for the production of dietary supplements must comply with the requirements of Ukrainian legislation and in their absence - standards established by the Codex Alimentarius Commission.
The opportunity to track  dietary supplements and any substance intended to be administered in dietary supplements should be ensured at all stages of production and circulation.
According to the proposed changes , the relevant contract may be concluded not only by the sponsor of the clinical trial , but also by their  authorized representative. In addition the mentioned procedures shall not be applied to the appeals against decisions made in the course of administrative violations proceedings. Farrington & Company, in conjunction with NCALC, introduced a poly bag recycling program at NCALCa€™s 105th annual convention in Atlantic Beach on Memorial Day weekend. Farrington & Company, presented this new program to the membership at the Sunday morning business session.
Farrington & Company will pick up recycled material at no charge when making regular scheduled deliveries to its customersa€™ locations.
Farrington & Company will be placed in the hands of companies that will recycle them into other plastic items such as fencing, soft drink crates, and other plastic products. Farrington & Company customer service department at 1-800-722-0374 or see their local Farrington representative.
Farrington & Company who sponsored the Presidenta€™s Reception and Consolidated Laundry Equipment Company who sponsored this yeara€™s Banquet. I plan to continue my education by attending classes at the Dry Cleaning and Laundry Institute beginning in July.
The kiosk could automatically notify the customers when their orders were ready.A  If for some reason the customer left the orders in the kiosk, the system would automatically reload the orders on the conveyor and send a message to the customer to let them know that the orders were left in the kiosk. Mammoth Scanning does not do restoration work, but preserves files and photos electronically in their current condition. Things would not come easy for me, as I was told, so I would need to work all the more diligently to stay up with others, be it physically, academically, or socially. Wartburg’s Habitat student organization would sponsor building days periodically, but periodically became not enough for me. I was on a trip that went down to New Orleans to help clean up after Hurricane Katrina, and I think had it not been for my strengthened service muscles, I might not have made it.
Over the course of one year attending college, however, I went from a flabby dreamer to a well-sculpted doer, and it was because I entrusted AmeriCorps with building my personal service-exercise program.
I have witnessed over the past three years, the power of human potential with countless volunteers.
Among peers, staff and the children, Howard, who has a physical disability, is famous for his enthusiasm. Daniel, who does not communicate verbally, helped Sarah to create a book by pointing to written words, which she then added to their collaborative story.
Through her VISTA experience, Shannon, who has Muscular Dystrophy, gained an awareness of accessibility issues in community technology centers. In the first, Andre developed a program that conveyed his experiences as a person with a disability to other young people facing a variety of life's challenges. Of his time there he writes, "Throughout my service I met some amazing individuals, traveled to some fascinating locations, and learned a variety of skills, but most importantly my service gave me the opportunity to recover, the ability to experience life with a smile. His family and teachers were impressed with the project because it provided Jared with a meaningful experience to give back to his community as well as taught him vital life skills.
His responsibilities at the program include creating an Accessible Materials workshop for teachers, designing inclusive lesson plans using the arts to build understanding about people with disabilities, supporting volunteer mentors, and leading art classes.
They gave the participants the opportunity to make the most objective opinion on the changes in the field of public procurements. During another session he presented a report on “Law Labyrinth of Legal Support and Appeal of Procurements Outcomes.
The term for making the decision on or the rejection of the state registration has been reduced to 10 business days. Please note, that the Ministry of Economic Development is mentioned for the first time in the context of the state registration of medicinal products and previously was not involved into any step of the registration process. In addition, we would like to mention a substantial expertise and due attention to this issue expressed by Antimonopoly Committee specialists. The reimbursement of insulin products costs shall be fulfilled at the rate of reference price for the medicinal product approved by the Ministry of Health of Ukraine. The patients shall receive their medication for a lowered price or for free in accordance with these categories.
Business entity should submit the relevant report not later than the 5th day of the month following the reporting month, and in December — not later than the 24th day of the reporting month. An important selection criterion is the presence of experience of the evaluation of the comparative efficacy (effectiveness), safety and cost-effectiveness of drugs.
This Order updates the mailing procedures for tax assessment notices to be sent to taxpayers by regulatory authorities. Today the AMCU increased the penalty up to 30% of the revenue from the sales of the products (goods, works, services) that violated the legislation on the protection against unfair competition.
In the end of the session the Legal Alliance senior associate Alexander Bondar presented a report on the new public procurements law, which practically implements the electronic procurements (electronic auction), electronic system of appeal, and the exchange of information, documents, submission of explanations in the electronic procurements system. In the course of his report the delegated had an opportunity to discuss the plans and implementations of 2015 and to share their expectations and forecasts for the coming year. After he passed the floor to the special guests of the conference - Aliona Kushnova, Judge at the regional Kiev administrative court, and Jonas Triggvason, Managing Partner, UPharma Consulting.
The session was traditionally opened with an analytical report on the status of the pharmaceutical market in 2015 presented by Irina Gorlova, General Director, SMD. Vitalii Savchuk, Senior Associate, Legal Alliance, presented a report on the most high-profile cases, investigations and court practices regarding the pharmaceutical industry. Bang purchased One Hour Koretizing.A  The good news is that none of the customersa€™ goods in either store were ruined.
The company specializes in web security, providing a system in the Microsoft network cloud where clients can opt to store their information.
Each week I would get together with my buddy to watch movies or WWE wrestling, or to go bowling. I took the initiative to get on the email list of the Habitat chapter from my area, so I could join them at their building sites more often. The labor that our group put in comparison to the monumental tasks that remained after we departed was enough to turn anyone off to the idea of service.
One of my priorities nowadays is to stay service-fit, so I can actively and productively contribute to my community through service and volunteerism.
She followed her VISTA service with a year long fellowship at a University Center of Excellence on Developmental Disabilities. His mother spoke of the project as being one of the few opportunities Jared had to mingle with peers outside of special education. Our joint efforts led us to the implementation of the project that only yesterday seemed to be almost impossible”. The reports should be submitted to local budgets holders who have been legitimately assigned for the execution of operating expenses of local budgets for preferential provision of insulin products to diabetic patients defined by the decisions on such expenditures in accordance with the legislation for the reimbursement to business entity of the amount stated in the register within 15 days upon the report receipt. In addition to a lot of interesting facts the reporter highlighted that the total volume of the medicinal products market in Ukraine amounted to 2.1 billion USD in 2015.
Craig said Josh would eventually like to tap into another market, individuals with family photographs they would like in electronic form. I decided to take part in AmeriCorps’ Iowa Campus Compact program primarily because I was feeling a strong call to volunteer and serve others. From helping to hang dry wall to nailing in hurricane brackets, I found the experience to be deeply gratifying, and once again, if it was not for ICAP, I would not have sought out this opportunity.
Risk taking ongoing with mold, mud and smell but no matter the circumstance, words of encouragement and utilization of God given talents were displayed continually. There she conducted research on accessibility in technology centers in low-income housing projects. Andre hopes to continue working within diverse communities to benefit young people, especially males, and help them develop leadership skills. Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development APRaD. The crux was that I did not feel confident in my own ability to follow through with such an important yet challenging call. Volunteers—young and old from all over the USA were all pitching in, using their muscles, heart and soul—were taking care of business in the heartland of Iowa. Daniel taught me some American Sign Language." The project helped the community understand that service is valuable, not only because everybody can participate, but everyone can also learn. Currently Shannon works as a Peer Guide and as the Information and Database Manager at an Independent Living Center. The AmeriCorps service experience has enabled him to develop the skills needed to be a community role model. In the framework of this session the participants discussed the adjustments in the personal data protection, as well as promotional activities and programs of the pharmaceutical companies. I knew from past experience that if the going got tough early on, if I felt that I was incapable of serving meaningfully or in a way that suited my capabilities, there was a chance that I might get disgruntled and quit altogether. She credits her VISTA experience with providing a background that developed her interest in creating access to technology for people with disabilities. Acknowledging that quitting was not an option, I turned to the Iowa Campus Compact program as a kind of service therapy. Witnessing the power of positive choice and seeing the power of the human body in mind, spirit consuming endless difficult work is like the best experience one could ever be involved with.
The best retail figures are shown by dietary supplements, patients care items and medicinal products, the worst figures – personal care products and cosmetics. I would be able to build up my service muscles with others, sharing our experiences and holding each other accountable.
Risk taking in helping others and taking on the challenges that flood duty entails has shown me the power of human potential when utilized with choice of helping others is what life is all about.
Session speakers - Zoya Zamikhovska, Junior associate, Lidiya Sangarovskaya-Gulach, Senior associate, and Andrii Gorbatenko, Associate partner, who presented to the audience their reports on medicinal products advertising, marketing agreements in the pharmacy sector, and distribution contracts. As a member of the AmeriCorps*VISTA program, I can't help but think how fruitful positiveness and perseverance does not take a backseat to negativity or giving up among those that choose to make a positive difference in people's life when the going gets rough. Andrii Gorbatenko emphasized the types of law infringements foreseen by the competition law, and paid the attendees attention to the provisions of distribution contracts, which are attracting a close attention of the Antimonopoly Committee of Ukraine, in particular the provisions regulating the reports, discounts and bonus payments.
Each of us knows how to make a positive choice and to serve others who need help when the circumstances arise. Personally I have had to deal with Lou Gehrig's disease amidst the risk taking of above work but I would not do anything different because adversity is life but positiveness as displayed overcomes all odds. Rynex Technologies did announce an association with Christeynsa€™ detergents to develop and distribute chemicals for their re-introduced solvent. What an awesome positive experience that I have seen is like the best medicine anyone could have no matter what personal health concerns are being dealt with. However take note as witnessed with flood recovery work that too many people are in action, facing life's challenges in a grandiose positive demeanor and that is the only way to live personally and collectively.



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