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Policy
Benefit for Sigmart 48mg will be newly established on Sept.
by
Kim, Jung-Ju
Aug 25, 2022 05:52am
Including Sigmart 48mg, JW Pharmaceutical's angina treatment, Nitroglycerin such as Nicorandil's drug, Elyson's Perlinganit 0.1% injection, which is used as a blood pressure control before and after surgery, and Verapamil HCl, Sanofi-Aventis Korea's Adenosine, are expected to be reimbursed next month. The benefits of Mycophenolate mofetil injections such as Roche's Cellcept, which is used to prevent rapid growth rejection of patients with kidney, heart, and liver transplants, and Ustekinumab injections such as Stella PFS 45mg, which treat psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, will be expanded. The Ministry of Health and Welfare decided to push for a partial revision notice of details on the criteria and methods of applying medical care benefits" and recently made an administrative notice. First of all, as of the 1st of next month, four drugs related to angina will be included in the benefit. The target drugs are JW Pharmaceutical's Sigmart 48mg, Elyson Perlinganit 0.1% injection, ILSUNG Isoptin, and Sanofi-Aventis Korea Adenocor. Sigmart 48mg is considered to induce maximum congestion during intra-coronary pressure measurement when no-reflow occurs during PCI, and Perlinganit 0.1% injection is recognized for spasm relief, coronary angiography, and intervention in patients with dysplasia. ILSUNG Isoptin is provided to prevent vasoconstriction during carotid coronary angiography and intervention, and Adenocor is provided to induce maximum congestion during no-reflow during PCI and intra-coronary pressure measurement. Mycophenolate-based drugs such as Roche's Cellcept will be expanded to patients confirmed to be in the WHO classification stage of lupus nephritis. Ustekinumab injections, such as Janssen Korea's psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis treatment Stelara PFS 45mg, do not show an appropriate response to a universal therapeutic agent or are not resistant to mediocre ulcerative colitis patients.
Policy
All domestic restrictions on PVA cut are agreed
by
Lee, Tak-Sun
Aug 24, 2022 05:56am
정해민 건보공단 약제관리실장이 23일 전문기자협의회와 브리핑을 하고 있다.Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, is briefing with the Korea Special Press Association on the 23rd. In the PVA negotiations that reflect this year's revised guidelines, all domestic pharmaceutical companies agreed with the NHIS. Initially, negotiations with some domestic pharmaceutical companies were expected to be difficult due to opposition to the retroactive application of the revised guidelines, but they reached an agreement within the target deadline. The agreed items will be reviewed by the Health Insurance Policy Review Committee this week and announced on September 1. Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, explained in a briefing with the Korea Special Press Association on the 23rd that 173 out of 175 items subject to negotiation were agreed. Type A negotiations are subject to an increase of more than 30% of the expected claims negotiated with the NHIS, and a product which cap has been adjusted by type price negotiations has increased by more than 60% or 10% from the previous year and increased by more than 5 billion won. This year's type C negotiations drew attention as the revised guidelines were reflected in April. The revised guidelines exclude less than 90% of the arithmetic average of the same main ingredient code and less than 2 billion won in annual claims from the negotiations. Previously, less than 100% of the arithmetic average and less than 1.5 billion won in annual claims were excluded. As a result, products from small and medium-sized pharmaceutical companies with an annual billing amount of less than 2 billion won will be excluded, but drugs with an arithmetic average of less than 90% will be included in the list, increasing the possibility of a drug price cut. In response, some pharmaceutical companies and the KPBMA have suggested that the guidelines should not be applied retroactively as of the previous year. However, regarding the retroactive application, the NHIS expressed its intention to reject it and began negotiations with individual pharmaceutical companies, saying that it shared it through meetings such as public-private consultative bodies. Jeong said, "We completed negotiations with individual pharmaceutical companies through sufficient consultation with pharmaceutical companies when negotiating with each company." As a result of the negotiations, an agreement was reached on 173 items in 52 product lines out of 175 items in 53 same product lines from 37 companies. Two items of one product line will be renegotiated, and the product is known to be two items of Xigduo XR of AstraZeneca Korea. Chief Jeong said, "The average cut rate of items that have been negotiated has decreased from last year, but the amount of fiscal savings has increased from last year." According to the revised guidelines, the average claim for drugs added due to the adjustment of the arithmetic average price was about 16.23 billion won, and the average claim for drugs excluded due to the upward revision of the claim was about 1.7 billion won. Director Jeong added, "As with the goal of revising the guidelines, we can see the reduction in administrative costs due to the exclusion of negotiations on drugs with small claims and the expansion of follow-up management of drugs with a large impact on insurance finances."
Policy
Gov't “will reinvestigate overused reimbursed items”
by
Lee, Jeong-Hwan
Aug 24, 2022 05:55am
The government will begin discussions on fiscal reform of the National Health Insurance areviewreivew the overused healthcare items ng on already-listed reimbursed items to expand essential healthcare and ensure the sustainability of NHI finances. On the 23rd, the Ministry of Health and Welfare launched and held the first meeting of the NHI Fiscal Reform Promotion Team that was established to strengthen essential healthcare and create a sustainable health insurance system. Relevant institutions, including the Ministry of Health and Welfare, National Health Insurance Service, and Health Insurance Review and Assessment Service will jointly participate in the Promotion Team to discover and promote projects for NHI fiscal reform. The NHI system has been improving access to medical care for the public, achieving a universal health insurance system in a short period of time since its implementation in 1977. As a result, Korea was able to achieve high levels of health outcomes in key indicators such as life expectancy and cancer mortality, etc. while spending less on medical expenses compared to the average spent by other OECD countries. However, in the process of reimbursing non-reimbursed items and reducing the burden borne by patients, an unexpected side effect where usage of some items have surged to a greater extent than expected arose. The government plans to operate the Promotion Team to review whether reimbursed items are being used in excess and prepare a measure for its management. In addition, the government plans to reinforce essential healthcare services that are necessary for the public by preparing a measure for the structural reform of medical expenditures and inducing reasonable and appropriate use of healthcare by examining whether any financial leaks in NHI fiances arose from ▲excessive medical use ▲the increase in the amount of non-reimbursed and reimbursed healthcare usage and their relationship with indemnity insurance ▲theft of health insurance qualifications ▲inappropriate use of the foreign dependent system, etc. For this, the Promotion Team plans to intensively discuss and announce plans to restore essential healthcare until October and prepare detailed implementation plans for each task. Ki-il Lee, second vice minister of MOHW said, “The Promotion Team will work to reinforce the management of reimbursed items and excessive medical use while maintaining the health insurance benefits received by the public. We will do our best to ensure a trusted and sustainable NHI system that covers essential areas of healthcare such as emergency, high-risk operations, childbirth, etc.”
Policy
Na Kyung-won is considering being the Minister of Health
by
Lee, Jeong-Hwan
Aug 23, 2022 06:04am
The opposition party is immediately criticizing the new government as Yoon Seok-yeol's office is reportedly considering Na Kyung-won, a former lawmaker with four-term experience, as a candidate for the next health and welfare minister. According to political circles of the ruling and opposition parties on the 22nd, President Yoon Seok-yeol put former lawmaker Na on the list of candidates for the welfare minister, which was compressed three times. She is said to have experience in related fields by working at the National Assembly's Health and Welfare Committee in the past and has experience and expertise in the field of health and welfare, including an honorary doctorate in social welfare at Soonchunhyang University in July. Having political power, such as serving as the floor leader of the Liberty Korea Party, the predecessor of the people's power, is also cited as the reason why former lawmaker Na is considered as the minister of welfare. Former lawmaker Na herself shows a cautious position or denies it. Regarding the appointment of the minister, former lawmaker Na is repeatedly answering in media interviews, saying, "There was no such thing at all," "There was no communication with the president's office," and "I didn't hear it." In response to this situation, politicians are speculating that it is a roundabout way of expressing their position to challenge the leadership of the people. She was recently mentioned as a strong candidate for the next party leader and said she was considering whether to challenge for the party's leadership. Na has recently been leading in several polls related to party leadership of the party. Lee Soo-jin, floor spokesman of the Democratic Party of Korea, said, "The appointment of Yoon Seok-yeol should signal a personnel reshuffle, not an extension of the personnel disaster," adding, "President Yoon is reportedly considering former lawmaker Na Kyung-won as a candidate for the welfare minister." "It is disastrous to consider a person who ran as a candidate for Seoul mayor in the 2011 local elections and was criticized for bathing teenagers in front of reporters as welfare minister," she pointed out. "President Yoon said at a 100-day press conference that the most important thing in the management of state affairs is the will of the people first and second," spokesman Lee Soo-jin said. "All policies, people, and attitudes should be changed." It is the will of the people to reform personnel and completely change the stance of state administration," she said.
Policy
Bill for 'state compensation for Paxlovid's side effects'
by
Lee, Jeong-Hwan
Aug 23, 2022 06:04am
A bill proposing the government's compensation for damages arising from the administration of COVID-19 treatments that were granted Emergency Use Authorization (EUA) such as Paxlovid or Lagevrio etc. has been filed. On the 22nd, People Power Party member Mi-Ae Kim proposed a bill as representative for the partial revision of the “Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis” which contained the abovementioned contents. Currently, side effects arising from COVID-19 vaccines are compensated based on the ‘Infectious Disease Control and Prevention Act,’ and the side effects arising after administration of drugs that are granted marketing authorization are compensated based on the “Pharmaceutical Affairs Act’ under respective side effect damage relief systems. However, under current laws, no clear grounds existed to provide compensation for side effects arising from the use of oral COVID-19 treatments that were granted EUA. To address this, People Power Party member, lawmaker Miae Kim submitted a bill that allows for the state to compensate for damages occurring due to the use of drugs approved for emergency use and the standards, scope, and procedure for compensation and investigation and appraisal for compensation payment to be applied the Pharmaceutical Affairs Act. As of the 22nd, the Ministry of Food and Drug Safety has granted EUA for 5 COVID-19 treatments – Evusheld inj., Lagevrio cap., Actemra inj., Vekury Powder For Concentrate For Solution For Infusion, and Paxlovid. If the National Assembly passes Kim’s bill, a safety net will be established for the state’s compensation for side effects that arise from the treatments that were granted EUA. In addition, the bill contained a provision to add separate subcommittees for each area of the Public Health Crisis Response Medical Product Safety Management and Supply Committee. It also provided a basis to entrust the maintenance and management of the crisis response medical product information system to the President of the Korea Institute of Drug Safety & Risk Management. Kim said, “We need to protect the lives and safety of our people from the damages and side effects caused by the use of EUA treatments."
Policy
When will the CSO reporting system be legislated?
by
Lee, Jeong-Hwan
Aug 23, 2022 06:04am
In consensus, the government and pharmaceutical industry are voicing the need to legislate the pharmaceutical contract sales organization (CSO) reporting system and urging the National Assembly to review the bill. Both the government and pharmaceutical industry share the position that a bill needs to be passed by the National Assembly to accurately identify CSOs that perform drug sales and promotion activities for pharmaceutical companies, such as one-person CSOs, to abolish indirect illegal rebates. On the 21st, the Ministry of Health and Welfare and the pharmaceutical industry were found to be busy closely following the National Assembly’s review and passage of the bill for the establishment of the CSO reporting system. Both the MOHW and industry believe that identifying the status of CSOs that are acting on behalf of domestic pharmaceutical sales is difficult because of the delay in the timely review of the CSO reporting system. In particular, the MOHW is closely eyeing the legislative timeline because the ministry can only publicly announce the standards and guidelines on the eligibility of the CSO reporting system after the bill is passed by the National Assembly. The CSO reporting system is a bill to regulate the CSO's drug promotion activities conducted on behalf of pharmaceutical companies that have not been reported to the government and local governments as illegal. The bill, if legislated, is expected to have a significant impact on the domestic pharmaceutical business environment. The MOHW plans to discuss and finalize the details of the system, such as the subject for the CSO report and the reporting system, with related ministries such as the Ministry of the Interior and Safety as soon as the bill passes NA review and is finalized. The industry has also long been awaiting the legislation of the CSO reporting system. Relevant laws have already been revised and CSOs are subject to filing and submitting expenditure reports. However, as the bill for the CSO reporting system is yet to be passed, the specific size of the CSOs industry is difficult to identify. This is why the criticism that a legal loophole has been created as the subjects for filing and submitting expenditure reports had been expanded, but those subject to the system are not identifiable, leaving open the risk for the rise of illegal indirect rebates. In addition, the bill to legislate the CSO reporting system needs to be passed for the pharmaceutical sales order education to be legislated, and the obligation to write and manage consignment reports be introduced for further reinforcement of the drug distribution order. Also, the passage of the bill will abolish the rebate attempts where some companies pay excessive promotion fees to CSOs for indirect rebates. An official from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “CSOs are being imposed the same level of obligations as pharmaceutical companies in filling out and submitting economic profit expenditure reports but without the passage of the CSO reporting system, which companies will be applied the system, including one-person CSOs cannot be clearly identified. The CSO system will allow the government to clearly identify and distinguish CSOs and assign the duty to prepare and manage consignment reports and prevent indirect rebates.” An official from a pharmaceutical company said, “Also, the system needs to be introduced to solidly establish a distribution order through pharmaceutical sale order education, etc. Currently, there is a widespread perception that CSOs are used as a window for rebates after being paid excessive promotional fees. The legislation is expected to have the effect of preventing excessive competition by allowing the pharmaceutical companies to pay appropriate fees to their CSOs while strengthening the government’s management and supervision function." Meanwhile, the MOHW plans to publicly disclose the expenditure report content submitted by pharmaceutical companies and medical device companies from January 2024 on its webpage and through other public systems. The MOHW and the pharmaceutical industry believe the CSO reporting system needs to be implemented in a timely manner in line with the public disclosure system for the expenditure report.
Policy
There is no concern about the disposal of COVID-19 PO tx
by
Lee, Jeong-Hwan
Aug 23, 2022 06:03am
Regarding the criticism that many of the COVID-19 PO treatments held by the quarantine authorities are likely to be discarded due to the expiration date early next year, it expressed that there is no problem in proper inventory management. As the use of PO drugs is increasing due to the re-proliferation of COVID-19 and an active prescription environment has been established, the current reserves can be used until November, so the introduction of additional supplies should be coordinated, not discarded. On the 18th, the KDCA made this announcement at a regular briefing for COVID-19. Some media reported that based on a report by the National Assembly's Budget Office, 700,000 of the 960,000 PO drugs brought in so far, will have to be discarded after the expiration date in February next year. In the briefing, a question was also asked about the criticism that many of the treatments will be discarded in February next year. The KDCA explained that in order to minimize damage to high-risk groups, it expanded hospital prescription institutions, increased pharmacies in charge, and encouraged medical staff to actively prescribe oral drugs. It also said that the current amount of oral drugs is doses for 690,000 people, which can be responded to by November this year, considering the recent weekly usage. The move is aimed at exhausting all of the current holdings before the disposal time in February next year. An official from the KDCA said, "We plan to flexibly adjust the additional introduction of the COVID-19 oral drug as it currently has a quantity that can be responded to by November rather than concerns about disposal." "We are also discussing with related agencies about extending the expiration date of Paxlovid and Lagevrio," he said. The official said, "We will push for proper inventory management without disposal for Paxlovid, which is scheduled to expire in February next year."
Policy
“Bio-vaccine fund will be created within the year”
by
Lee, Jeong-Hwan
Aug 22, 2022 05:53am
President Yoon Suk-Yeol reconfirmed his new government’s plan to raise and create a K-Bio·Vaccine Fund that focuses investments on Phase III trials within the year. The government will induce investments with pan-ministerial support and also accumulate data on 1 million people to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. Also, a public policy-based fee system will be implemented to reinforce essential healthcare such as less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand, such as pediatrics and childbirth. On the 19th, the Ministry of Health and Welfare reported the new government’s operation plan that contained the abovementioned plans to the president. ◆Making the leap to become a global biohealth hub=The MOHW announced plans for Korea to make the leap and become a global biohealth hub. It plans to strengthen pan-ministerial support to attract investment from companies in Korea and abroad and raise and create a K-Bio·Vaccine Fund that focuses on Phase III trial investments within the year to attract private investments. Also, the ministry will provide regulatory relief by reorganizing the innovative medical device designation system within and announcing step-by-step implementation plans to innovate the biohealth regulations within the year. In addition, a ‘National Integrated Bio Big Data’ system will be established to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. With the goal of accumulating data on 1 million people, the government will apply for a preliminary feasibility study within the year. Also, a ‘Health Information Expressway’ will be created to safely manage and relay personal health and medical data for customized use by HCPs. R&D investments to establish health security and resolve national challenges will also be expanded, with the goal of reaching ₩1 trillion in 2025. In particular, the investment will be concentrated on securing core technologies such as mRNA (messenger ribonucleic acid) platforms, antiviral drugs, and universal vaccines. ◆Advancing capabilities for infectious disease response= The government’s 3rd-year COVID-19 countermeasures were also presented in the report. The plan is to promote precise, targeted quarantine in infection-vulnerable areas while maintaining daily life. Therefore, targeted distancing measures such as restricting visits and prohibiting outdoor visits or stays will be implemented in vulnerable facilities that have a high frequency of confirmed COVID-19 cases. In order to prevent group infection and progression to severe disease in such infection-vulnerable facilities, preemptive tests for workers will be expanded, and confirmed patients will be promptly treated to prevent further infection or disease progression. Also, access to testing will be reinforced by extending weekend and nighttime operation hours of screening centers (602 centers) and temporary screening centers (6 centers). Also, progression to severe disease in high-risk groups such as the elderly will be prevented by utilizing one-stop medical institutions (currently 12 locations) that can test, treat, and prescribe COVID-19 treatments within one day. As of 00:00, the proportion of COVID-19 patients aged 60 years or older among patients with severe·critical disease and deaths were 86.8% (427 patients) and 91.6% (76 patients), respectively. Also, outpatient prescriptions of COVID-19 treatments will be made possible at the patient's regular hospitals with the allowance of outpatient prescriptions in such hospitals and an increased number of pharmacies that handle COVID-19 treatments. A system for intensive treatment of severely ill patients and rapid response to emergency patients will also be prepared. Communication will also be strengthened. Ki-Seok Jeong, Chairman of the National Infectious Disease Crisis Response Advisory Committee, will be appointed Director-General of Special Response Central Disaster and Safety Countermeasure Headquarters, and will be running and explaining COVID-19-related news to the public in easy terms through the YouTube channel, ‘COVID-19 TV.’ Also, communication with the medical community will be strengthened by operating a city-regional medical consultative body with doctors’ associations in cities and provinces. ◆Expanding essential healthcare through introduction of public policy-based fee system, etc. =Also, the government will work to expand essential healthcare through the introduction of a public policy-based fee system and reform of the national health insurance expenditures to prevent the recurrence of tragedies such as the recent death of the nurse at Asan Medical Center. Essential healthcare refers to services that pose a serious threat to the lives of the people if not urgently provided, or are inadequately provide due to reduced medical demand. A public policy-based fee system will be implemented to strengthen the grounds for essential healthcare, in less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand such as pediatrics and childbirth. Compensation for high-risk high-difficulty operations and emergency operations that are less frequent but high-risk such as aortic dissection, heart, and brain surgery that are shunned will be strengthened by increasing the policy-based premium fee. Also, support for the recovery of infrastructure on childbirth will be reinforced through measures such as raising fees and support for vulnerable regions. Also, compensation will be reinforced and infrastructure expanded after evaluating essential healthcare to identify areas in deficit such as children's hospitals. The plan also contained measures to increase the listing of essential healthcare and high-priced drugs through a thorough re-evaluation of existing reimbursed items that cause excessive use such as ultrasound and MRI, the improvement of standards for foreign dependents, and preventing theft of health insurance qualifications.
Policy
The PVA exception to COVID-19 cold drug is actively applied
by
Lee, Tak-Sun
Aug 22, 2022 05:52am
Pharmaceutical Industry Says "Response After Gathering Internal Opinions" The Ministry of Health and Welfare said it would actively apply the correction method to the pharmaceutical industry's request to exclude cold drugs used in COVID-19 from PVA. Although it is not excluded from the negotiation, the policy is to actively apply exception rules to prevent damage to drug price cuts. First, the pharmaceutical industry plans to collect opinions on the proposal and respond through a public-private consultative body. However, as the Ministry of Health and Welfare's official position has been reported, the pharmaceutical industry is also expected to consider using the correction method in a more advantageous way. According to the industry on the 18th, the Ministry of Health and Welfare sent an official letter to pharmaceutical organizations such as KPBMA, saying that if the COVID-19 drug is selected for negotiations, it will be actively applied. The KPBMA suggested that COVID-19 drugs be excluded from PVA to actively support the production of COVID-19 symptom treatments. Prime Minister Han Duck-soo said at a meeting of the COVID-19 Central Disaster and Safety Countermeasures Headquarters on the 12th, "As the number of COVID-19 confirmed patients increases, we will encourage and support the expansion of supply and demand of cold medicines such as antipyretics. He said, "We will ease PVA, which cuts prices when the use of drugs increases, so that manufacturers can increase production." The pharmaceutical industry also had some expectations for Prime Minister Han's remarks. The plan proposed by the Ministry of Health and Welfare is interpreted as an extension. The Ministry of Health and Welfare and the NHIS also conveyed their intention to correct the COVID-19 cold medicine in accordance with related regulations through a public-private consultative body, so not all demands from the pharmaceutical industry to be excluded from the negotiation were accepted this time. According to the provisions of Article 10 (2) of the PVA Negotiation Detailed Operation Guidelines, exceptions are made when applying PVA in the case of drugs used to support the treatment of infectious diseases. The Ministry of Health and Welfare explained that if the cold medicine that the Ministry of Food and Drug Safety encourages production for the treatment of COVID-19 is selected as a PVA target, the relevant regulations will be actively applied. When calculating the negotiation reference price, the amount of use prescribed for COVID-19 treatment is excluded, or the amount of use at a specific time (e.g., February to August) is excluded. However, the correction method will be decided after sufficient discussion with related associations through a public-private consultative body. The pharmaceutical industry plans to seek countermeasures after internal discussions. An official from the Pharmaceutical Association said, "We would like to hear the opinions of pharmaceutical companies on the proposal of the Ministry of Health and Welfare and communicate with the government through a public-private consultative body at the end of the month." As the government's policy has become official, the industry is expected to discuss countermeasures accordingly. This is because the demand to continue to be excluded from the negotiation target may work against the discussion process.
Policy
Manufacturing for development allowed during suspensions
by
Lee, Hye-Kyung
Aug 19, 2022 05:53am
An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period. According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for product development or to prepare data for approval changes, are allowed during the manufacturing suspension period. This interpretation was provided after a number of queries on 'whether manufacturing for the purpose of product development is allowed during the suspension of manufacturing business period, and whether such manufactured units can be sold,’ were submitted on the national e-petition website, e-People. According to Article 76 of the Pharmaceutical Affairs Act, if a manufacturer of drugs or its importer violates the Pharmaceutical Affairs Act or any order issued under the Pharmaceutical Affairs Act, the Minister of Food and Drug Safety may revoke permission, approval, or registration held by the manufacturer of drugs, issue an order to prohibit manufacturing or importing products, or issue an order to fully or partially suspend his or her business for a period of up to one year. Also, according to Article 95, Annex 8-10 of the ‘Regulation on Safety of Medicinal Products,’ if companies perform the suspended business during the suspended period, their license or registration may be revoked. Regarding the provisions, the industry posted an inquiry on the e-People website on whether companies subject to manufacturing suspension dispositions may conduct manufacturing activities for the purpose of preparing submission data for the product’s approval change (change of consignee) or product development (and if allowed, whether the manufactured lot may be sold). After review, the MFDS said, “acts of manufacturing for non-sale, product development purposes (to prepare data for approval changes, etc.) are allowed during the manufacturing suspension period. However, the sale of the lot manufactured for approval changes, etc. or product development during the manufacturing suspension period is not allowed."
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