Regulations Amending the Food and Drug Regulations (1475 Good Manufacturing Practices)

Transcription

1 Canada Gazette: Vl. 147, N. 10 May 8, 2013 Registratin SOR/ April 26, 2013 FOOD AND DRUGS ACT Regulatins Amending the Fd and Drug Regulatins (1475 Gd Manufacturing Practices) P.C April 25, 2013 His Excellency the Gvernr General in Cuncil, n the recmmendatin f the Minister f Health, pursuant t sectin 30 (see ftnte a) f the Fd and Drugs Act (see ftnte b), makes the annexed Regulatins Amending the Fd and Drug Regulatins (1475 Gd Manufacturing Practices). REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1475 GOOD MANUFACTURING PRACTICES) AMENDMENTS 1. The definitin expiratin date in subsectin C (1) f the Fd and Drug Regulatins (see ftnte 1) is replaced by the fllwing: expiratin date means (a) in the case f a drug in dsage frm, the earlier f the fllwing dates, expressed at minimum as a year and mnth: (i) the date up t and including which the drug maintains its labelled ptency, purity and physical characteristics, and (ii) the date after which the manufacturer recmmends that the drug nt be used; and (b) in the case f an active ingredient, whichever f the fllwing dates is applicable, expressed at minimum as a year and mnth: (i) the retest date, r (ii) the date after which the manufacturer recmmends that the active ingredient nt be used. (date limite d utilisatin) 2. (1) The definitin whlesale in subsectin C.01A.001(1) f the Regulatins is repealed. (2) Subsectin C.01A.001(1) f the Regulatins is amended by adding the fllwing in alphabetical rder: active ingredient means a drug that, when used as a raw material in the fabricatin f a drug in dsage frm, prvides its intended effect. (ingrédient actif)

2 active pharmaceutical ingredient means an active ingredient that is used in the fabricatin f a pharmaceutical. (ingrédient actif pharmaceutique) bulk prcess intermediate means an active ingredient that is used in the fabricatin f either a drug f bilgical rigin that is listed in Schedule C t the Act r a drug that is listed in Schedule D t the Act. (prduit intermédiaire en vrac) whlesaler means a persn wh is nt a distributr described in sectin C.01A.003 and wh sells any f the fllwing drugs ther than at retail sale: (a) a drug in dsage frm that is listed in Schedule C r D t the Act r in Schedule F t these Regulatins, r a cntrlled drug as defined in subsectin G (1); (b) an active ingredient; r (c) a narctic as defined in the Narctic Cntrl Regulatins. (grssiste) (3) Subsectin C.01A.001(2) f the Regulatins is replaced by the fllwing: (2) In this Divisin and in Divisin 2, drug des nt include a dilute drug premix, a medicated feed as defined in subsectin 2(1) f the Feeds Regulatins, 1983, an active ingredient that is fr veterinary use r a drug that is used nly fr the purpses f an experimental study in accrdance with a certificate issued under sectin C Sectin C.01A.003 f the Regulatins is replaced by the fllwing: C.01A.003. This Divisin and Divisins 2 t 4 apply t the fllwing distributrs: (a) a distributr f an active ingredient r a drug in dsage frm that is listed in Schedule C t the Act; and (b) a distributr f a drug fr which the distributr hlds the drug identificatin number. 4. Subsectin C.01A.004(1) f the Regulatins is replaced by the fllwing: C.01A.004. (1) Subject t subsectin (2), n persn shall, except in accrdance with an establishment licence, (a) fabricate, package/label r imprt a drug; (b) perfrm the tests, including examinatins, required under Divisin 2; (c) distribute a drug as set ut in sectin C.01A.003 that is nt an active pharmaceutical ingredient; r (d) whlesale a drug that is nt an active pharmaceutical ingredient. 5. (1) Paragraphs C.01A.005(f) and (g) f the Regulatins are replaced by the fllwing: (f) whether the applicant prpses t carry ut a licensed activity in respect f an active ingredient;

3 (g) the address f each building in Canada in which the applicant prpses t fabricate, package/label, test as required under Divisin 2 r stre drugs, specifying fr each building the activities and the categries f drugs and, fr each categry, the dsage frm classes, if any, and whether any drug will be in a sterile frm; (2) Subparagraph C.01A.005(m)(i) f the Regulatins is replaced by the fllwing: (i) the name and address f each fabricatr, packager/labeller and tester f the drug and the address f each building in which the drug is fabricated, packaged/labelled r tested, specifying fr each building the activities and the categries f drugs and, fr each categry, the dsage frm classes, if any, and whether any drug will be in a sterile frm, (3) Paragraph C.01A.005(n) f the Regulatins is replaced by the fllwing: (n) in the case f any ther imprter, the name and address f each fabricatr, packager/labeller and tester f the drugs prpsed t be imprted and the address f each building in which the drugs will be fabricated, packaged/labelled and tested, specifying fr each building the activities and the categries f drugs and, fr each categry, the dsage frm classes, if any, and whether any drug will be in a sterile frm; and 6. (1) Item 4 f Table I t sectin C.01A.008 f the Regulatins is replaced by the fllwing: Item Activities 4. Distribute as set ut in paragraph C.01A.003(a) a drug that is nt an active pharmaceutical ingredient (2) Item 7 f Table I t sectin C.01A.008 f the Regulatins is replaced by the fllwing: Item Activities 7. Whlesale a drug that is nt an active pharmaceutical ingredient (3) Table II t sectin C.01A.008 f the Regulatins is amended by adding the fllwing after item 1: Item Categries f drugs 1.1 Active ingredients 7. The Regulatins are amended by adding the fllwing after sectin C : C N persn shall sell a drug that they have fabricated, packaged/labelled, tested r stred unless they have fabricated, packaged/labelled, tested r stred it in accrdance with the requirements f this Divisin.

4 C (1) N persn shall imprt an active ingredient int Canada fr the purpse f sale unless they have in Canada a persn wh is respnsible fr its sale. (2) N persn wh imprts an active ingredient int Canada shall sell any lt r batch f it unless the fllwing appear n its label: (a) the name and civic address f the persn wh imprts it; and (b) the name and address f the principal place f business in Canada f the persn wh is respnsible fr its sale. Use in Fabricatin C N persn shall use an active ingredient in the fabricatin f a drug unless it is fabricated, packaged/labelled, tested and stred in accrdance with the requirements f this Divisin. 8. Subsectins C (2) t (4) f the Regulatins are replaced by the fllwing: (2) Every fabricatr and packager/labeller and, subject t subsectins (3) and (4), every distributr referred t in paragraph C.01A.003(b) and imprter f a drug shall maintain a system t ensure that any lt r batch f the drug fabricated and packaged/labelled n premises ther than their wn is fabricated and packaged/labelled in accrdance with the requirements f this Divisin. (3) Subsectin (2) des nt apply t a distributr if the drug is fabricated, packaged/labelled and tested in Canada by a persn wh hlds an establishment licence that authrizes thse activities in respect f that drug. (4) Subsectin (2) des nt apply t a distributr r imprter if the drug is fabricated r packaged/labelled in an MRA cuntry at a recgnized building and bth f the fllwing requirements are met: (a) the address f the building is set ut in their establishment licence; and (b) they retain a cpy f the batch certificate fr each lt r batch f the drug that they receive. 9. Sectins C and C f the Regulatins are replaced by the fllwing: C (1) Every fabricatr, packager/labeller, whlesaler, distributr referred t in sectin C.01A.003 and imprter f a drug shall have n their premises in Canada a quality cntrl department that is supervised by persnnel described in sectin C (2) Except in the case f a whlesaler r a distributr referred t in paragraph C.01A.003(a), the quality cntrl department shall be a distinct rganizatinal unit that functins and reprts t management independently f any ther functinal unit, including the manufacturing, prcessing, packaging r sales unit. C (1) Except in the case f a whlesaler r a distributr referred t in paragraph C.01A.003(a), n lt r batch f a drug shall be made available fr further use in fabricatin r fr sale unless the persn in charge f the quality cntrl department apprves the sale r the further use.

5 (2) A drug that is returned t its fabricatr, packager/labeller, whlesaler, distributr referred t in sectin C.01A.003 r imprter shall nt be made available fr further use in fabricatin r fr further sale unless the persn in charge f the quality cntrl department apprves the further sale r further use. (3) N lt r batch f a raw material r packaging/labelling material shall be used in the fabricatin r packaging/labelling f a drug unless the persn in charge f the quality cntrl department apprves the use. (4) N lt r batch f a drug shall be reprcessed unless the persn in charge f the quality cntrl department apprves the reprcessing. 10. Subsectins C (1) and (2) f the Regulatins are replaced by the fllwing: C (1) Each lt r batch f a drug shall, befre it is made available fr further use in fabricatin r fr sale, be tested against the specificatins fr that drug. (2) N lt r batch f a drug shall be made available fr further use in fabricatin r fr sale unless it cmplies with the specificatins fr that drug. 11. Sectins C t C f the Regulatins are replaced by the fllwing: C (1) A packager/labeller f a drug, a distributr referred t in paragraph C.01A.003(b) and an imprter f a drug ther than an active ingredient shall perfrm the finished prduct testing n a sample f the drug that is taken either (a) after receipt f each lt r batch f the drug n their premises in Canada; r (b) befre receipt f each lt r batch f the drug n their premises in Canada if the fllwing cnditins are met: (i) the packager/labeller, distributr r imprter (A) has evidence satisfactry t the Directr t demnstrate that drugs sld t them by the vendr f that lt r batch are cnsistently manufactured in accrdance with and cnsistently cmply with the specificatins fr thse drugs, and (B) undertakes peridic cmplete cnfirmatry testing, with a frequency satisfactry t the Directr, and (ii) the drug has nt been transprted r stred under cnditins that may affect its cmpliance with the specificatins fr that drug. (2) If the packager/labeller, distributr r imprter receives a lt r batch f a drug n their premises in Canada the useful life f which is mre than 30 days, the lt r batch shall be tested fr identity and the packager/labeller shall cnfirm the identity after the lt r batch is packaged/labelled. (3) Subsectins (1) and (2) d nt apply t a distributr if the drug is fabricated, packaged/labelled and tested in Canada by a persn wh hlds an establishment licence that authrizes that activity.

6 (4) Subsectins (1) and (2) d nt apply t a distributr r imprter if the drug is fabricated, packaged/labelled and tested in an MRA cuntry at a recgnized building and bth f the fllwing requirements are met: (a) the address f the building is set ut in their establishment licence; and (b) they retain a cpy f the batch certificate fr each lt r batch f the drug that they receive. Recrds C (1) Every fabricatr, packager/labeller, distributr referred t in paragraph C.01A.003(b) and imprter shall maintain all f the fllwing recrds n their premises in Canada fr each drug that they fabricate, package/label, distribute r imprt: (a) except in the case f an imprter f an active pharmaceutical ingredient, master prductin dcuments fr the drug; (b) evidence that each lt r batch f the drug has been fabricated, packaged/labelled, tested and stred in accrdance with the prcedures described in the master prductin dcuments; (c) evidence that the cnditins under which the drug was fabricated, packaged/labelled, tested and stred are in cmpliance with the requirements f this Divisin; (d) evidence that establishes the perid during which the drug in the cntainer in which it is sld r made available fr further use in fabricatin will meet the specificatins fr that drug; and (e) evidence that the finished prduct testing referred t in sectin C was carried ut and the results f that testing. (2) Every distributr referred t in paragraph C.01A.003(b) and imprter shall make available t the Directr, n request, the results f testing perfrmed n raw materials and packaging/labelling materials fr each lt r batch f a drug that it distributes r imprts. (3) Every fabricatr shall maintain n their premises written specificatins fr all raw materials and adequate evidence f the testing f thse raw materials referred t in sectin C and f the test results. (4) Every persn wh packages a drug shall maintain n their premises written specificatins fr all packaging materials and adequate evidence f the examinatin r testing f thse materials referred t in sectin C and f any test results. (5) Every fabricatr, packager/labeller and tester shall maintain n their premises in Canada detailed plans and specificatins f each building in Canada where they fabricate, package/label r test drugs and a descriptin f the design and cnstructin f thse buildings. (6) Every fabricatr, packager/labeller and tester shall maintain n their premises in Canada persnnel recrds in respect f each persn wh is emplyed t supervise the fabricatin, packaging/labelling and testing f drugs, including the persn s title, respnsibilities, qualificatins, experience and training.

7 C (1) All recrds and evidence f the fabricatin, packaging/labelling, finished prduct testing referred t in sectin C and strage f a drug in dsage frm that are required t be maintained under this Divisin shall be retained fr ne year after the expiratin date f the drug unless the persn s establishment licence specifies sme ther perid. (2) Subject t subsectin (4), all recrds and evidence f the fabricatin, packaging/labelling, finished prduct testing referred t in sectin C and strage f an active ingredient that are required t be maintained under this Divisin shall be retained in respect f each lt r batch f the active ingredient fr the fllwing perid unless the persn hlds an establishment licence that specifies sme ther perid: (a) in the case f an active ingredient that has a retest date, three years after the lt r batch has been cmpletely distributed; r (b) in any ther case, ne year after the expiratin date f the lt r batch. (3) Subject t subsectin (4), all recrds and evidence f the raw material testing referred t in sectin C and f the testing f packaging/labelling materials that are required t be maintained under this Divisin shall be retained fr five years after the raw materials and packaging/labelling materials were last used in the fabricatin r packaging/labelling f a drug unless the persn s establishment licence specifies sme ther perid. (4) If a fabricatr is required t maintain recrds and evidence in respect f the same active ingredient under subsectins (2) and (3), they shall maintain them fr the lngest perid that is applicable. C (1) Every whlesaler, distributr referred t in sectin C.01A.003 and imprter f a drug in dsage frm shall retain recrds f sale f each lt r batch f the drug, which enable them t recall the lt r batch frm the market, fr ne year after the expiratin date f that lt r batch unless their establishment licence specifies sme ther perid. (2) Every distributr f an active ingredient referred t in paragraph C.01A.003(a) and every whlesaler and imprter f an active ingredient shall retain recrds f sale f each lt r batch f the active ingredient, which enable them t recall the lt r batch frm the market, fr the fllwing perid unless the persn hlds an establishment licence that specifies sme ther perid: (a) in the case f an active ingredient that has a retest date, three years after the lt r batch has been cmpletely distributed; r (b) in any ther case, ne year after the expiratin date f the lt r batch. C (1) On receipt f a cmplaint r any infrmatin respecting the quality f a drug r its deficiencies r hazards, every fabricatr, packager/labeller, whlesaler, distributr referred t in sectin C.01A.003 and imprter f the drug shall make a recrd f the cmplaint r infrmatin that cntains the fllwing: (a) the results f any investigatin carried ut under subsectin C (2) and, if applicable, the crrective actin taken; r (b) the name and business address f the persn in charge f the quality cntrl department t whm the cmplaint r infrmatin was frwarded under subsectin C (2.1) and the date n which it was frwarded.

8 (2) Recrds referred t in subsectin (1) shall be retained fr the fllwing perid unless the persn hlds an establishment licence that specifies sme ther perid: (a) in the case f a drug in dsage frm, ne year after the expiratin date f the lt r batch f the drug; and (b) in the case f an active ingredient, (i) if the active ingredient has a retest date, three years after the lt r batch has been cmpletely distributed, r (ii) in any ther case, ne year after the expiratin date f the lt r batch f the active ingredient. 12. The Regulatins are amended by adding the fllwing after sectin C : C Every distributr f an active ingredient referred t in paragraph C.01A.003(a) and every fabricatr, packager/labeller, whlesaler and imprter f an active ingredient shall add all f the fllwing infrmatin t the dcumentatin that accmpanies the active ingredient, immediately after any like infrmatin that has been added by anther persn: (a) their establishment licence number, r if there is nne, their name, address, telephne number, fax number and address; (b) an indicatin whether they have fabricated, packaged/labelled, whlesaled, distributed r imprted the active ingredient and the date n which that activity was carried ut; (c) the expiratin date; and (d) the lt number. 13. Sectin C f the Regulatins is replaced by the fllwing: C (1) Every distributr referred t in paragraph C.01A.003(b) and imprter f a drug in dsage frm shall retain in Canada a sample f each lt r batch f the packaged/labelled drug fr ne year after the expiratin date f the drug unless their establishment licence specifies sme ther perid. (2) Subject t subsectin (4), the fabricatr f a drug in dsage frm shall retain a sample f each lt r batch f raw materials used in the fabricatin fr tw years after the materials were last used in the fabricatin unless their establishment licence specifies sme ther perid. (3) Subject t subsectin (4), the fabricatr f an active ingredient shall retain a sample f each lt r batch f it fr the fllwing perid unless their establishment licence specifies sme ther perid: (a) in the case f an active ingredient that has a retest date, three years after the lt r batch has been cmpletely distributed; r (b) in any ther case, ne year after the expiratin date f the lt r batch. (4) If a fabricatr is required t maintain samples in respect f the same active ingredient under subsectins (2) and (3), they shall maintain them fr the lngest perid that is applicable. 14. Sectins C and C f the Regulatins are replaced by the fllwing:

9 C (1) Every distributr referred t in paragraph C.01A.003(b) and imprter f a drug in dsage frm shall establish the perid during which each drug in the package in which it is sld will cmply with the specificatins fr that drug. (2) Every fabricatr and imprter f an active ingredient shall establish the perid during which each drug in the package in which it is sld will cmply with the specificatins fr that drug. C (1) Every distributr referred t in paragraph C.01A.003(b) and imprter f a drug in dsage frm shall mnitr, by means f a cntinuing prgram, the stability f the drug in the package in which it is sld. (2) Every fabricatr and imprter f an active ingredient shall mnitr, by means f a cntinuing prgram, the stability f the drug in the package in which it is sld. 15. The definitin drug in sectin C f the Regulatins is replaced by the fllwing: drug means a drug that is listed in Schedule C t the Act that is in dsage frm r a drug that is an active ingredient f bilgical rigin that can be used in the preparatin f a drug listed in that Schedule; (drgue) 16. The definitin drug in sectin C f the Regulatins is replaced by the fllwing: drug means a drug that is listed in Schedule D t the Act that is in dsage frm r a drug that is an active ingredient that can be used in the preparatin f a drug listed in that Schedule; (drgue) TRANSITIONAL PROVISIONS 17. (1) Every persn wh, n the day n which these Regulatins cme int frce, fabricates, packages/labels, tests r imprts an active pharmaceutical ingredient may cntinue t d s withut an establishment licence if they submit an applicatin fr a licence under sectin C.01A.005 f the Fd and Drug Regulatins within three mnths after that day. (2) Subsectin (1) applies until the determinatin f the licence applicatin under sectin C.01A.008 r C.01A.010 f the Fd and Drug Regulatins. 18. The Fd and Drug Regulatins, as they read immediately befre the cming int frce f these Regulatins, cntinue t apply in respect f whle bld and bld cmpnents fr a perid f ne year after the day n which these Regulatins cme int frce. COMING INTO FORCE 19. These Regulatins cme int frce six mnths after the day n which they are published in the Canada Gazette, Part II.