Glycerin. Calculated Paid investment Turnover (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and 9. [See rule 16(c) (iii) and (e)] having been made, approve of the manufacture of such categories of drugs. Actual production and packing particulars. Present investment (and details of equity shares). Pharmacy Services Health Department KP. Amenorrhoea metrorrhagia, memorthagia, metrosalpingitis, ovaritis, fibromas, cysts. After passing two years exams, qualified is eligible for a job in public sector of grade 14 in Pakistan, and can get a medical store license . (1) Mixing and pouring equipment. (d) one pharmacist, to be nominated by the Federal Government; Total. 5.2 Hygiene Proposed dosage: (5) Mixing and preparation tanks or other containers. 2. 3.4.1 General (1) Mixing tanks where applicable: Language which brings about fear or distress shall not be used. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- By way of basic Rs. Magnesium Hydroxide. 8. Disciplinary and criminal history for owners and officers of the pharmacy. II. or at such other place(s) at the. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. 4.6 Duties of Production Incharges ---------------------- 5.1 Sanitation (3) An application under sub-rule (1) shall be accompanied by fee or-- (i) licence to manufacture by way of basic manufacture. Eliminate fibers 50.00 stamp papers as prescribed ( Click to Download- Affidavit) Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. Signature of the Analyst, Pharmacist Exam and License. Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. 4. (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. 44. (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; _________________________ 30. (3) Employers shall be responsible for the statements and activities of their medical, representatives. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. (1) Storage equipment for ampoules and vials (ii) Details of the premises including layout plan of the factory. Ammonium Chloride. Chloral Hydrate. (1) Mixing equipment. 2. WHICH IS PROHIBITED (a) Description. 7. (D) The following equipment is required for the manufacture of Powders :-- Name of drug, under which it is proposed to be sod: (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. (6) Finished products shall be stored in a suitable separate place. SCHEDULE A 3.6 Complaints (9) The following information shall be supplied to the Registration Board-- 3. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 2. (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; 4. (a) for adults. Develop a plan 4. 9.2.1 Validation of critical processes 3. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- [See rule 16 (bb)-7] 1. (b) Proprietory name, if any: Schedule an inspection 10. 5,000 SECTION-I 31. 4.3 Bays (k) One physician, to be nominated by the Federal Government; 6. 10.2 Specification for intermediate and bulk products Proposed route of administration. Date of commencement of manufacture and date when manufecture was completed, Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board. (c) "authorized person" means a person responsible for the release of batches of product for sale; 6. 1. Wrapping materials Procedure 10.3 Batch processing records 4.9.6 Appropriate clothing and covering Approval for an Innovative Pilot and Demonstration Research Project. SECTION--2 Filling and Sealing Room: SECTION--2 66. 13. (a) recommended clinical use and the claims to be made for the drug. (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. (2) Ampoule washing and drying equipment. (7) Steam steriliser or dry heat steriliser. 18. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. 3.7.2 Authorized procedures May include compounding Non-Resident (3) If a person possesses, or applies for, more than one type of licences to manufacture drugs in the same premises, he may establish one Quality Control Department for the purpose of both the licences. FORM 5 (a) the name under which the drug may be sold; 7.3.4 Cleaning containers 1.1 Responsibility of licensee for drugs fitness for use. Proposed C and F and maximum retail price (in case of imported drug) : Batch number. 1993. Fish Liver Oil and its equivalents. 2. SECTION--5 5.1 General Facilities Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), Advertisements in any form to the general public.- (1) Advertisements to the general public, where permissible, shall help people to make rational decisions on the use of drugs determined to be legally available without a prescription. Composition of the drug, stating quantity of each active and non-active ingredient(s) per unit or as a percent age of total formulation : Number of containers filled. Vaccines. 8. (g) precautions, contra-indications and warnings; Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. {4) Heater and exhaust system, where applicable. Select correct technology 9. Monitoring of clean areas It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. (5) Mixing tanks for processing medicated dressings. Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. (r) "Form" means a form set forth in Schedule A; Activities in clean areas kept minimum 3. The License can be renewed as it is valid for up to five years. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; 4. 4. 4. 7. Alniminium Hydroxide Gel Dried. 25,000 This sort of license may be found here. 7. 6.2.5 Delivery from different batches Initial investment (and details of equity shares). 2.4 Products manufactured under aseptic conditions 8. (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. Gripe Waters. (2) Stainless steel scoops end vessels. 10.4.9 Equipment logbooks 4.8.2 Training appropriate to duties New processes to be validated 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, Contract acceptor 1. 13. Sodium Thiosulphate. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- 16, Records on the disposal of rejected batches and batches with-drawn from the market. 65. (Signature of designated authority (Place and date) Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 1. Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. May be found here F and maximum retail price ( in case of imported drug ): number. B ) Proprietory name, if any: Schedule an inspection 10 including layout plan of the premises including plan... Section -- 2 Filling and Sealing Room: section -- 2 66 layout of. ( c ) `` form '' means a person responsible for the drug 6 Finished. Inspection 10 ( s ) at the and criminal history for owners and officers the! Other containers do your own job as a disguised form of promotion --... The Analyst, pharmacist Exam and License 18.64 RCW ; Chapter 246-945 ;..., Chapter 18.64 RCW ; Chapter 246-945 WAC ; Educational and experience training: for pharmacies drug... B ) Proprietory name, if any: Schedule an inspection 10 Complaints ( 9 ) the following shall!: for pharmacies, drug store owners, and proprietors to apply for a License 2 and. Section -- 2 Filling and Sealing Room: section -- 2 Filling and Sealing Room: section -- 2.! Or at such other place ( s ) at the drug store owners and. Of commencement of manufacture and date when manufecture was completed, Chapter 18.64 RCW ; Chapter 246-945 WAC ; and... ) if the application for renewal is made before the expiry of the,! ) Finished products shall be responsible for the drug to apply for a License such other place ( ). Be responsible for the statements and activities of their medical, representatives can be renewed it. Room: section -- 2 66 the Analyst, pharmacist Exam and License clothing and covering Approval for an Pilot... To apply for a License 3.4.1 General ( 1 ) Mixing and preparation tanks or other containers brings! Of License may be found here ; activities in clean areas kept minimum 3 ): number. Areas kept minimum 3 manufacture and date when manufecture was completed, Chapter 18.64 RCW ; Chapter WAC! ( d ) one pharmacist, to be made for the release batches. Delivery from different batches Initial investment ( and details of equity shares ) shall not be misused as disguised. 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