DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (<strong>DRGD</strong>)8.7.3 TEMPLATE FOR AN APPEAL LETTERLETTERHEAD SYARIKAT PEMEGANG PENDAFTARAN PRODUKNama dan alamat pemegangTarikh:Y. B. Menteri Kesihatan Malaysiad/a Biro Pengawalan Farmaseutikal KebangsaanKementerian Kesihatan MalaysiaJalan Universiti, Peti Surat 319,46730 Petaling Jaya(u.p. Setiausaha PBKD)Y. B.,PERATURAN 18 – RAYUAN TERHADAP PENOLAKAN PERMOHONANPENDAFTARANNAMA PRODUK : Sila nyatakan nama produk (Please state the product name)NO. RUJUKAN : Sila nyatakan nombor pendaftaran produk(Please state reference number of the product)Dengan segala hormatnya, pihak kami ingin membuat rayuan terhadap penolakanpermohonan produk seperti di atas.2. Alasan – alasan rayuan serta data tambahan/ maklumat akan dihantar kepadapihak Y.B. dalam tempoh *90 hari / 180 hari dari tarikh surat ini dikeluarkan.Sekian, terima kasih.Yang benar,Tandatangan Wakil Pemegang(NAMA WAKIL PEMEGANG)Jawatan Wakil Pemegang* Potong mana-mana yang tidak berkaitan.(Please cross out words that do not apply.)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 86
Drug Registration Guidance Document (<strong>DRGD</strong>)SECTION C: QUALITY CONTROLThe requirement for the submission of the protocol of analysis (POA), analyticalmethod validation (AMV) and product samples for laboratory testing are presented inthis section.The submission of POA and AMV to the Centre for Quality Control shall be done viathe online system (Quest system) and also using hardcopies, once payment for theregistration has been confirmed. Documents to be submitted are listed below:Documents to be submitted via online Quest system1. E9 : Complete protocol of analysis for finished product includingpreservatives and diluents (if any).2. E10 : Summary of AMV which includes all the relevant validationcharacteristics, its acceptance criteria and results.3. E11 : Certificate of analysis for active drug substance (1 batch) andrecent batches of finished product (3 different batches).Documents to be submitted as hardcopy:1. Certificate of analysis for active drug substance (1 batch) and recent batches offinished product (3 different batches)2. Complete protocol of analysis for active drug substances and finished product(including preservatives and diluents, if any)3. Complete testing method for the AMV.4. Complete results for the AMV with all relevant validation parameters, includingacceptance criteria and supporting raw data (e.g. chromatograms, spectrums etc.)Note:1. A cover letter consisting of the following information should be enclosed with everyhard copy document submission:i) Name of product;ii) Reference Number/ Protocol Number;iii) Contact person (name/ email address/ telephone no.);iv) Name and address of company.2. Documents submitted should be well organized and indexed.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 87
Page 1 and 2:
Drug Registration Guidance Document
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37: Drug Registration Guidance Document
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
Page 224 and 225:
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233:
- All information must be provided
Page 234 and 235:
Page 236 and 237:
Page 238 and 239:
Page 240 and 241:
Page 242 and 243:
1.2 EXEMPTION FROM PRODUCT REGISTRA
Page 244 and 245:
Page 246 and 247:
Page 248 and 249:
Page 250 and 251:
Page 252 and 253:
Page 254 and 255:
Page 256 and 257:
Page 258 and 259:
Page 260 and 261:
Page 262 and 263:
Page 264 and 265:
Page 266 and 267:
Page 268 and 269:
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
For product containing Red Yeast Ri
Page 294 and 295:
Page 296 and 297:
Page 298 and 299:
Page 300 and 301:
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
Page 308 and 309:
Page 310 and 311:
Page 312 and 313:
Page 314 and 315:
Page 316 and 317:
Page 318 and 319:
Page 320 and 321:
Page 322 and 323:
Page 324 and 325:
Page 326 and 327:
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486 and 487:
Page 488 and 489:
Page 490 and 491:
Page 492 and 493:
Page 494 and 495:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Create successful ePaper yourself

Delete template?

Save as template?