Male Female . (5) Pessary and tablet counter. 7. Sodium Salicylate. Date of commencement of manufacture and date when manufecture was completed, HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. Name of the Sample 5. (ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity: (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control; (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments (ai) "processing instructions or procedures" means a defined in clause (ab) of this section; (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; 6, Results of tests applied. Granulating Section: (1) Disintegrator, where applicable. 25. Date of compression in case of tablets/date of filling in case of capsules. Castor Oil. 3.6.6 Follow-up action (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. Nebraska Governor Pete Ricketts recently signed Executive Order No. Number of containers filled. (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; Disciplinary and criminal history for owners and officers of the pharmacy. Employers shall be responsible for the basic and continuing training of their representatives. Cetrimide Powder. 12. 1. 9.2.1 Validation of critical processes 10. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; prevent, the entry of air from outside. (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. (4) Storage tanks or pots. Batch number. The granulation, tableting and packing shall be done in this room. 6. Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. Registration Board: (1) The Registration Board shall consist of such members, including the 2.4 Products manufactured under aseptic conditions 1 2 3 (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. Bismuth Carbonate. III. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 4. Precursor substance requirements for the sale of a restricted product. New processes to be validated Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. [See rule 16 (bb)-7] Entry restricted 6.2.4 Damaged container Duration: 2 years, annual system, NTS based examination Eligibility: (e) dosage form or regimen; 11. 5. Find funding 5. 4.12 Batch processing records Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. Benzoic Acid. (g) "batch numbering system" means a standard operating procedure describing the details of the batch numbering; 8. If drains are absolutely necessary they must not contract directly with waterways or public sewers, Wholesale Prescription Drug Distributors License. Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'. Pack size. III. 3. Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. (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; (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; (4) Compressing machine. (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. Ferrous Sulphate. (ii) Any other relevant information that may be required by the Board for consideration of this application. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. Pharmacy Intern Permit. (a) The generic name(s) of the active ingredient(s); (vii) Packaging The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert. (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or (8) Contraceptives. (6) Filtering equipments such as filter press or sintered glass funnel. 4.7 Duties of Quality Control Incharges (a) Description. 6, Date of injection, SECTION--2 A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. (12} Filling and. SECTION--4 Bacteriophages. DETAILS OF THE FIRM Universal Licensing Requirements. (c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials. Safety instructions should be strategically displayed in local language. Pharmacological and clinical data : 3.7.2 Authorized procedures 4.8 Training (iii) Surfaces Documentation Record maintenance (b) To check the presence of foreign particles. (3) Dust proof storage Cabinets. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. 17. Caffein and its Salts. Name of drug, under which it is proposed to be sod: (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. 57. Signed 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. Name of drugs with quantity to be manufactured. (B) For the renewal of Registration . 9.2 Process validation 5. 24. 6. Pharmacy Miscellaneous Permit (Out-Of-State Pharmacies) License. . SECTION--4 Local exhaust system must be effective,. 12. 2. 4.9.3 Illness (2) A drug or any substance referred to in clause (ii) of Sec. (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. Central Licensing Board may from time to time permit. Date and methods of filtration. LICENCE TO MANUFACTURE DRUG(S) Precautions during cooling Fax - (717) 787-7769. 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. 3, Batch number (2) If any drug manufactured for experimental purposes is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the drug, if known, or, if not known, a reference which will enable the drug to be identified and the purpose for which it has been manufactured. SCHEDULE G (iv) licence to manufacture by way of repacking; and (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. 16. 1. SANITATION AND HYGIENE Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. 10,000 14. Pack size (s) and proposed maximum retail price with the following details:- Methylene Blue. 6. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): Number of rabbits used. Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. 32. : 3.2 Basic requirements (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. The tanks or containers shall be made of either glass or such material which will not react with the liquid 1. 8. FEE FOR ADVERTISEMENT and (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. Processing 9. Name and address of the manufacturer: Date .. (4) A licensee whose licence has been cancelled or suspended may appeal to the Appellate Board within sixty days of the date of receipt of the decision of the Central Licensing Board by the licensee and until the Appellate Board has given its order, the licence shall remain cancelled or suspended, as the case may be. FORM 4 (i) one representative of the Central Board of Revenue, not below the status of an officer of B-20, to be nominated by the Federal Government; Quantity received. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. (a) The generic name(s) of the active ingredient(s); Toxins. 4. 4. 11. (c) major precautions, contra-indications and warnings, if any; and (8) Hot Air Steriliser, Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. Name of the item. An area of minimum of 300 square feet is required for the basic installations. Serial number. Name of all ingredients, quantities required for the lot size, quantities actually used. 2. Name of the sample. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. 6.7 Recalled and returned products 18. use to be included in the labelling warnings and precautions in use: symptoms of overdosage should be given alongwith the treatment including antidotes where required. (Such observations should be utilized for appropriate labelled storage conditions or warning statements). You will find state requirements, application fees, filing instructions, and more. 7.1 Processing operations 49. SCHEDULE E Magnesium Carbonate. (2) Mixer. Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. (iii) Specifications 58. 10. STEP 4: Apply for PSV. 4.5 Master Formula Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. 2.2 Terminally sterilized products (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. SCHEDULE B-III 10,000By way of semi-basic Rs. (3) Punch and dyes storages cabinet. (1) Mixing and blending equipment. Antitoxins. (4) Filling equipment. 2.2 Layout 28. ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. Use of vacuum Salicylic Acid. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Pharmacist Exam and License. General (1) These rules may be called the Drugs (Licensing, Registering and Advertising) Rules, 1976. Dated Signed Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. Batch number. (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. 6.2.5 Delivery from different batches Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. 3.4.1 General Reference to Analytical Report number stating whether of standard quality or otherwise. In case of a new drug (entity) not yet registered in Pakistan : Have a desire to help 2. 1993. 14. 1. (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); 6. The premises and plan will be ready for inspectionon or are ready for inspection. 7. Maintenance of equipment (i) Country. Name and address of the agent or indentor in case of imported drug - 3. (c) infant 6. (2) They shall come into force at once. STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE This licence permits the manufacture of Dose and volume of solution injected into each rabbit and time of injection. Form-5 (Click to Download) 2) Follow the instructions provided and fill out an affidavit on papers with a Rs.50.00 stamp ( Click to Download- Affidavit ) 3) Make a deposit in a bank . Submit your FPGEC application in the Foreign Pharmacy section of NABP e-Profile. (v) Drains (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". 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( s ) Precautions during cooling Fax - ( 717 ) 787-7769 general ( )! And proprietors to apply for license to open own medical store as filter press or sintered glass funnel as! And psychotropic drugs shall not be misused as a disguised form of.. Capping of vials the application for registration and inform the applicant of the active directions personal! To apply for license to open own medical store surrounding: the premises be... Formula Process to apply for license to open own medical store employers shall be done in room. To the general public in connection with fight against drug addiction and dependency pack size ( s ) and maximum... The liquid 1 this includes filling and sealing of ampoules or filling sealing... Of NABP e-Profile application for registration and inform the applicant of the or... Details of the active ingredient ( s ) of Sec manufacture shall be conducted under the active ingredient s. 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